Pub Date : 2025-01-01DOI: 10.1177/15347354241313334
Zhengzheng Yang, Haiming Li, Lei Chen, Shujiao Li, Dong Chen, Taicheng Lu, Tongjing Ding, Ruiyang Han, Peiyu Cheng, Xiaomin Wang
Background: The prevalence of brain metastases (BM) in lung cancer patients is notably high and is associated with poor prognoses. The efficacy of standard treatment regimens in improving intracranial progression-free survival (IPFS) for lung cancer BM is markedly limited. While traditional Chinese medicine (TCM) has been effective in enhancing the quality of life and prognosis of lung cancer patients, its efficacy in treating BM remains unreported.
Case presentation: Here, we present a case of a middle-aged female with lung cancer BM, whose condition was assessed as progressive post-standard treatment including two local surgeries (both involving resection of cerebellar space-occupying lesions), stereotactic radiotherapy, chemotherapy and EGFR-TKIs. Subsequently, she underwent treatment with the traditional Chinese herbal formula gubenxiaoyi (GBXY). The patient was treated with GBXY for a total duration of 55 months. After treatment, a significant reduction of about 50% in intracranial lesions was observed, accompanied by an extension of both Intracranial Progression-Free Survival (IPFS) and Cognitive Deterioration-Free Survival (CDFS) exceeding 50 months.
Conclusion: These results demonstrate that in patients with lung cancer brain metastases (BM) unresponsive to standard treatments, GBXY not only has the potential to effectively prolong IPFS and decelerate cognitive decline, but may also contribute to a reduction in intracranial tumor burden. This suggests that GBXY could be a promising therapeutic option that warrants further investigation.
{"title":"Long-Term Intracranial Progression-Free Survival in Lung Cancer Brain Metastases Extended Beyond 50 Months with Gubenxiaoyi Formula (GBXY): A Groundbreaking Case Study.","authors":"Zhengzheng Yang, Haiming Li, Lei Chen, Shujiao Li, Dong Chen, Taicheng Lu, Tongjing Ding, Ruiyang Han, Peiyu Cheng, Xiaomin Wang","doi":"10.1177/15347354241313334","DOIUrl":"10.1177/15347354241313334","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of brain metastases (BM) in lung cancer patients is notably high and is associated with poor prognoses. The efficacy of standard treatment regimens in improving intracranial progression-free survival (IPFS) for lung cancer BM is markedly limited. While traditional Chinese medicine (TCM) has been effective in enhancing the quality of life and prognosis of lung cancer patients, its efficacy in treating BM remains unreported.</p><p><strong>Case presentation: </strong>Here, we present a case of a middle-aged female with lung cancer BM, whose condition was assessed as progressive post-standard treatment including two local surgeries (both involving resection of cerebellar space-occupying lesions), stereotactic radiotherapy, chemotherapy and EGFR-TKIs. Subsequently, she underwent treatment with the traditional Chinese herbal formula gubenxiaoyi (GBXY). The patient was treated with GBXY for a total duration of 55 months. After treatment, a significant reduction of about 50% in intracranial lesions was observed, accompanied by an extension of both Intracranial Progression-Free Survival (IPFS) and Cognitive Deterioration-Free Survival (CDFS) exceeding 50 months.</p><p><strong>Conclusion: </strong>These results demonstrate that in patients with lung cancer brain metastases (BM) unresponsive to standard treatments, GBXY not only has the potential to effectively prolong IPFS and decelerate cognitive decline, but may also contribute to a reduction in intracranial tumor burden. This suggests that GBXY could be a promising therapeutic option that warrants further investigation.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354241313334"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780649/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1177/15347354241304415
Jane Kersten, Timo Niels, Annika Tomanek, Freerk T Baumann
Context: Due to therapeutic side effects and physical weakness, patients are not always able to carry out strenuous and lengthy exercises. Hence, this study investigated the effectiveness and feasibility of a short-term Whole-body electromyostimulation (WB-EMS) for oncological patients during and after anticancer treatment. The primary aim was to ensure the feasibility of WB-EMS training. Furthermore, the effects of WB-EMS training were investigated over a period of 2 weeks on parameters such as quality of life, body composition and physical performance.
Method: Thirteen cancer patients with different diagnosis, disease stages and treatment state were included. They participated in supervised WB-EMS sessions 4 times over a 2-week period. Physical functioning, body composition, depression, fatigue, and quality of life were measured before and after the intervention period. Moreover, a pre-post measurement of the patients' perceived body constitution was conducted in every exercise session.
Results: All included patients (n = 13) were able to complete the 4 WB-EMS sessions. At the end of the 2 weeks, a significant increase of the muscle strength could be observed. Additionally, patients improved their cardiovascular fitness. The body composition analyses showed significant reductions in body lean mass and extracellular water. Muscle mass remained unchanged. Furthermore, patients reported an improved perceived body constitution reduced pain and discomfort following all 4 WB-EMS sessions.
Conclusion: This study suggests that WB-EMS is safe and feasible for cancer patients. Furthermore, it showed that even after 2 weeks, improvements concerning the physical performance and patient-reported outcomes can be achieved. This study indicates benefits of WB-EMS as short-term exercise methode in cancer patients, that could be utelised in fields such as cancer prehabilitation.
Trial registration: This trial has been registered with the ISRCTN-Registry (ISRCTN68069634).
{"title":"Short-term WB-EMS in Cancer Patients: Positive Effects After 2 Weeks of Exercise-A Single-arm Trial.","authors":"Jane Kersten, Timo Niels, Annika Tomanek, Freerk T Baumann","doi":"10.1177/15347354241304415","DOIUrl":"10.1177/15347354241304415","url":null,"abstract":"<p><strong>Context: </strong>Due to therapeutic side effects and physical weakness, patients are not always able to carry out strenuous and lengthy exercises. Hence, this study investigated the effectiveness and feasibility of a short-term Whole-body electromyostimulation (WB-EMS) for oncological patients during and after anticancer treatment. The primary aim was to ensure the feasibility of WB-EMS training. Furthermore, the effects of WB-EMS training were investigated over a period of 2 weeks on parameters such as quality of life, body composition and physical performance.</p><p><strong>Method: </strong>Thirteen cancer patients with different diagnosis, disease stages and treatment state were included. They participated in supervised WB-EMS sessions 4 times over a 2-week period. Physical functioning, body composition, depression, fatigue, and quality of life were measured before and after the intervention period. Moreover, a pre-post measurement of the patients' perceived body constitution was conducted in every exercise session.</p><p><strong>Results: </strong>All included patients (n = 13) were able to complete the 4 WB-EMS sessions. At the end of the 2 weeks, a significant increase of the muscle strength could be observed. Additionally, patients improved their cardiovascular fitness. The body composition analyses showed significant reductions in body lean mass and extracellular water. Muscle mass remained unchanged. Furthermore, patients reported an improved perceived body constitution reduced pain and discomfort following all 4 WB-EMS sessions.</p><p><strong>Conclusion: </strong>This study suggests that WB-EMS is safe and feasible for cancer patients. Furthermore, it showed that even after 2 weeks, improvements concerning the physical performance and patient-reported outcomes can be achieved. This study indicates benefits of WB-EMS as short-term exercise methode in cancer patients, that could be utelised in fields such as cancer prehabilitation.</p><p><strong>Trial registration: </strong>This trial has been registered with the ISRCTN-Registry (ISRCTN68069634).</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354241304415"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11705350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142948428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1177/15347354241307038
Bernardino Clavo, Delvys Rodríguez-Abreu, Saray Galván-Ruiz, Mario Federico, Angeles Cánovas-Molina, Yolanda Ramallo-Fariña, Carla Antonilli, Gretel Benítez, Himar Fabelo, Carla García-Lourve, Damián González-Beltrán, Ignacio J Jorge, Francisco Rodríguez-Esparragón, Gustavo M Callico
Background: Numbness and tingling secondary to chemotherapy-induced peripheral neuropathy (CIPN) are frequent side effects that limit chemotherapy treatment and quality of life. Successful treatments for CIPN are limited. This preliminary report shows the potential long-term effects of ozone treatment in the management of persistent numbness and tingling secondary to CIPN.
Methods: Ozone treatment was administered by rectal insufflation in 15 patients (female/male: 8/7, age: 66 years old) suffering from persistent numbness and tingling secondary to grade-2 or grade-3 CIPN. Planned ozone treatment consisted of 40 sessions over 4 months. The initial concentration of 10 μg/mL was progressively increased to 30 μg/mL. The initial gas volume of 180 mL/session was progressively increased to 300 mL/session if tolerated. Before and after ozone treatment, and at 3- and 6- months after the end of treatment, they were assessed (i) the grade of CIPN-toxicity, and (ii) the self-reported decrease in numbness and tingling.
Results: After ozone treatment, 47% of patients experienced a decrease in the grade of CIPN-toxicity (P = .016), and 67% of patients reported a decrease in numbness and tingling ≥50% (P = .002). These effects were maintained at 3- and 6- months after the end of O3T.
Conclusions: In this retrospective report, patients with persistent numbness and tingling secondary to CIPN showed clinically relevant and long-term improvements after ozone treatment. The magnitude and duration of the observed effects merit further research and support our ongoing clinical trials.
{"title":"Long-Term Effects of Ozone Treatment in Patients with Persistent Numbness and Tingling Secondary to Chemotherapy-Induced Peripheral Neuropathy. A Retrospective Study.","authors":"Bernardino Clavo, Delvys Rodríguez-Abreu, Saray Galván-Ruiz, Mario Federico, Angeles Cánovas-Molina, Yolanda Ramallo-Fariña, Carla Antonilli, Gretel Benítez, Himar Fabelo, Carla García-Lourve, Damián González-Beltrán, Ignacio J Jorge, Francisco Rodríguez-Esparragón, Gustavo M Callico","doi":"10.1177/15347354241307038","DOIUrl":"10.1177/15347354241307038","url":null,"abstract":"<p><strong>Background: </strong>Numbness and tingling secondary to chemotherapy-induced peripheral neuropathy (CIPN) are frequent side effects that limit chemotherapy treatment and quality of life. Successful treatments for CIPN are limited. This preliminary report shows the potential long-term effects of ozone treatment in the management of persistent numbness and tingling secondary to CIPN.</p><p><strong>Methods: </strong>Ozone treatment was administered by rectal insufflation in 15 patients (female/male: 8/7, age: 66 years old) suffering from persistent numbness and tingling secondary to grade-2 or grade-3 CIPN. Planned ozone treatment consisted of 40 sessions over 4 months. The initial concentration of 10 μg/mL was progressively increased to 30 μg/mL. The initial gas volume of 180 mL/session was progressively increased to 300 mL/session if tolerated. Before and after ozone treatment, and at 3- and 6- months after the end of treatment, they were assessed (i) the grade of CIPN-toxicity, and (ii) the self-reported decrease in numbness and tingling.</p><p><strong>Results: </strong>After ozone treatment, 47% of patients experienced a decrease in the grade of CIPN-toxicity (<i>P</i> = .016), and 67% of patients reported a decrease in numbness and tingling ≥50% (<i>P</i> = .002). These effects were maintained at 3- and 6- months after the end of O<sub>3</sub>T.</p><p><strong>Conclusions: </strong>In this retrospective report, patients with persistent numbness and tingling secondary to CIPN showed clinically relevant and long-term improvements after ozone treatment. The magnitude and duration of the observed effects merit further research and support our ongoing clinical trials.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354241307038"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724412/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1177/15347354241313048
Mark J Miller, Daniel C Hughes, Nydia T Darby, Tim Calderon, Darpan I Patel, Monica C Serra, Amelie G Ramirez, Alexis Ortiz, Gustavo J Almeida
Introduction: Balance problems arising from cancer and its treatments can significantly impact daily functionality and quality of life. Improving balance as part of a cancer treatment plan could result in better patient outcomes. Thus, the aim of this study was to determine whether an integrative therapeutic yoga intervention can improve balance in a heterogenous population of cancer survivors (CS).
Methods: This is a secondary analysis of data from a 16-week feasibility study where therapeutic yoga was supplemented with psychosocial support to maximize health-related quality of life in adult CS of any stage and site. In this study, we investigated balance, as it has been shown to be an important outcome in CS due to its role in physical function and quality of life. The intervention included therapeutic yoga three times per week for 16 weeks and daily psychosocial support provided via text message. Participants' balance was assessed while standing on a pressure mat with feet together, eyes opened and closed, for 30 seconds in each condition. Data on the "sway path distance" (displacement of the center of gravity) in the two conditions were obtained. Changes in balance after the intervention (from baseline to follow-up) were analyzed using paired-sample t-tests. Changes in balance were also assessed using responder analysis. We described the proportion of participants that improved their balance or not based on 10% difference from baseline scores.
Results: Of the 29 participants included, 22 (76%) completed post-assessments. Changes in both balance assessment conditions were not statistically significant (eyes opened: 80.06 ± 374.99, p = .702; eyes closed: -1.82 ± 24.01, p = .068). Responder analysis showed that 8 participants improved their balance with eyes opened, while 8 worsened, and 6 did not change. Analysis of balance with eyes closed showed that 5 improved, 8 worsened, and 9 did not change.
Conclusion: This secondary analysis of data from a heterogenous cohort of adult CS did not support our hypothesis at the group level. However, at the individual level, responder analysis indicated improved balance in some survivors. Future research is needed to determine factors related to the cancer experience which might mediate balance outcomes to inform better integrative interventions.
{"title":"Balance Changes in Adult Cancer Survivors Participating in a 16-Week Therapeutic Yoga Program.","authors":"Mark J Miller, Daniel C Hughes, Nydia T Darby, Tim Calderon, Darpan I Patel, Monica C Serra, Amelie G Ramirez, Alexis Ortiz, Gustavo J Almeida","doi":"10.1177/15347354241313048","DOIUrl":"10.1177/15347354241313048","url":null,"abstract":"<p><strong>Introduction: </strong>Balance problems arising from cancer and its treatments can significantly impact daily functionality and quality of life. Improving balance as part of a cancer treatment plan could result in better patient outcomes. Thus, the aim of this study was to determine whether an integrative therapeutic yoga intervention can improve balance in a heterogenous population of cancer survivors (CS).</p><p><strong>Methods: </strong>This is a secondary analysis of data from a 16-week feasibility study where therapeutic yoga was supplemented with psychosocial support to maximize health-related quality of life in adult CS of any stage and site. In this study, we investigated balance, as it has been shown to be an important outcome in CS due to its role in physical function and quality of life. The intervention included therapeutic yoga three times per week for 16 weeks and daily psychosocial support provided via text message. Participants' balance was assessed while standing on a pressure mat with feet together, eyes opened and closed, for 30 seconds in each condition. Data on the \"sway path distance\" (displacement of the center of gravity) in the two conditions were obtained. Changes in balance after the intervention (from baseline to follow-up) were analyzed using paired-sample t-tests. Changes in balance were also assessed using responder analysis. We described the proportion of participants that improved their balance or not based on 10% difference from baseline scores.</p><p><strong>Results: </strong>Of the 29 participants included, 22 (76%) completed post-assessments. Changes in both balance assessment conditions were not statistically significant (eyes opened: 80.06 ± 374.99, <i>p</i> = .702; eyes closed: -1.82 ± 24.01, <i>p</i> = .068). Responder analysis showed that 8 participants improved their balance with eyes opened, while 8 worsened, and 6 did not change. Analysis of balance with eyes closed showed that 5 improved, 8 worsened, and 9 did not change.</p><p><strong>Conclusion: </strong>This secondary analysis of data from a heterogenous cohort of adult CS did not support our hypothesis at the group level. However, at the individual level, responder analysis indicated improved balance in some survivors. Future research is needed to determine factors related to the cancer experience which might mediate balance outcomes to inform better integrative interventions.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354241313048"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11733873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: To observe the clinical efficacy of Dendrobium officinale in the treatment of radiotherapy-induced oral mucositis in nasopharyngeal carcinoma patients, and to explore its regulating effect on immune function and oral microbiota by comparing immune-related factors and oral microbiota before and after the intervention.
Methods: We conducted a randomized double-blinded controlled trial in Zhejiang Cancer Hospital. Sixty patients with nasopharyngeal cancer combined with radiotherapy-induced oral mucositis were randomly divided into a study group and control group, with 30 cases in each group The study group used compound vitamin B12 solution and Dendrobium tea drink, and the control group simply used compound vitamin B12 solution rinse. When the patients developed radiotherapy-induced oral mucositis (at the time of 10F radiotherapy), and after 1 month of Dendrobium treatment (at the end of radiotherapy), the salivary flow rate was measured without stimulation to evaluate the degree of oral mucositis and the clinical efficacy. We also detected the content of EGF in saliva and the content of IL-10 and IL-11 in serum, and analyzed the differences in microbial community structure. All patients consented before enrollment.
Results: The salivary flow rate and oral mucosal fraction of the study group after treatment were significantly improved, which was better than that of the control group(P < .05). The content of IL-10 in the study group after treatment increased significantly compared with that before treatment(P < .05). There was a significant difference between the oral flora of the study group before and after treatment (Unique OTU counts: 5390 vs 3906), and there was also a difference between the oral flora of the study group and control group after treatment (Unique OTU counts: 5671 vs 5439). After treatment, Erysipelotrichales (Phylum Firmicutes, LDA score = 2.80, P = .034), Leptotrichiaceae (Fusobacteria,LDA score = 3.38, P = .030) and Campylobacteraceae (Proteobacteria, LDA score = 3.35, P = .026) were significantly enriched in the study group. The use of Dendrobium officinale in nasopharyngeal carcinoma patients with radiotherapy-induced oral mucositis showed little difference in microbial diversity and abundance, but there were significant differences among oral bacteria genera.
Conclusions: Dendrobium officinale is effective in the treatment of radiotherapy-induced oral mucositis, which may be related to the improvement of salivary gland function and regulation of the oral microenvironment. Dendrobium officinale may reduce the symptoms of radiotherapy-induced oral mucositis by affecting the systemic cellular immune function. It may reduce the secretion of pro-inflammatory factors of the relevant flora by directly changing the oral flora and regulating the oral micro-ecology.
目的:观察铁皮石斛治疗鼻咽癌放疗性口腔黏膜炎的临床疗效,并通过比较干预前后免疫相关因素及口腔微生物群,探讨其对免疫功能及口腔微生物群的调节作用。方法:在浙江省肿瘤医院进行随机双盲对照试验。将60例鼻咽癌合并放疗性口腔黏膜炎患者随机分为研究组和对照组,每组30例,研究组使用复合维生素B12溶液和石斛茶饮,对照组单纯使用复合维生素B12溶液冲洗。当患者发生放疗性口腔黏膜炎时(10F放疗时),以及在石斛治疗1个月后(放疗结束时),在不刺激的情况下测量唾液流速,评价口腔黏膜炎的程度及临床疗效。我们还检测了唾液中EGF的含量和血清中IL-10和IL-11的含量,并分析了微生物群落结构的差异。所有患者在入组前均同意。结果:研究组治疗后唾液流速和口腔黏膜分数均显著改善,优于对照组(P P P = 0.034),研究组纤毛菌科(Fusobacteria,LDA评分= 3.38,P = 0.030)和弯曲菌科(Proteobacteria, LDA评分= 3.35,P = 0.026)显著丰富。在鼻咽癌放疗性口腔黏膜炎患者中使用铁皮石斛,其微生物多样性和丰度差异不大,但口腔细菌属间差异显著。结论:铁皮石斛治疗放疗性口腔黏膜炎有效,其作用机制可能与改善唾液腺功能、调节口腔微环境有关。铁皮石斛可能通过影响全身细胞免疫功能来减轻放疗所致口腔黏膜炎的症状。它可能通过直接改变口腔菌群,调节口腔微生态,减少相关菌群促炎因子的分泌。
{"title":"Effect of Dendrobium Officinale on Radioactive Oral Mucositis of Nasopharyngeal Carcinoma and Changes of Oral Microecology.","authors":"Jiaying Yang, Yuancai Liu, He Yao, Mengying Sun, Yangbo Tong, Guanjun Ma, Zhuo Chen, Xiang Qian, Aiqin Zhang","doi":"10.1177/15347354251313524","DOIUrl":"10.1177/15347354251313524","url":null,"abstract":"<p><strong>Objective: </strong>To observe the clinical efficacy of Dendrobium officinale in the treatment of radiotherapy-induced oral mucositis in nasopharyngeal carcinoma patients, and to explore its regulating effect on immune function and oral microbiota by comparing immune-related factors and oral microbiota before and after the intervention.</p><p><strong>Methods: </strong>We conducted a randomized double-blinded controlled trial in Zhejiang Cancer Hospital. Sixty patients with nasopharyngeal cancer combined with radiotherapy-induced oral mucositis were randomly divided into a study group and control group, with 30 cases in each group The study group used compound vitamin B12 solution and Dendrobium tea drink, and the control group simply used compound vitamin B12 solution rinse. When the patients developed radiotherapy-induced oral mucositis (at the time of 10F radiotherapy), and after 1 month of Dendrobium treatment (at the end of radiotherapy), the salivary flow rate was measured without stimulation to evaluate the degree of oral mucositis and the clinical efficacy. We also detected the content of EGF in saliva and the content of IL-10 and IL-11 in serum, and analyzed the differences in microbial community structure. All patients consented before enrollment.</p><p><strong>Results: </strong>The salivary flow rate and oral mucosal fraction of the study group after treatment were significantly improved, which was better than that of the control group(<i>P</i> < .05). The content of IL-10 in the study group after treatment increased significantly compared with that before treatment(<i>P</i> < .05). There was a significant difference between the oral flora of the study group before and after treatment (Unique OTU counts: 5390 vs 3906), and there was also a difference between the oral flora of the study group and control group after treatment (Unique OTU counts: 5671 vs 5439). After treatment, Erysipelotrichales (Phylum Firmicutes, LDA score = 2.80, <i>P</i> = .034), Leptotrichiaceae (Fusobacteria,LDA score = 3.38, <i>P</i> = .030) and Campylobacteraceae (Proteobacteria, LDA score = 3.35, <i>P</i> = .026) were significantly enriched in the study group. The use of Dendrobium officinale in nasopharyngeal carcinoma patients with radiotherapy-induced oral mucositis showed little difference in microbial diversity and abundance, but there were significant differences among oral bacteria genera.</p><p><strong>Conclusions: </strong>Dendrobium officinale is effective in the treatment of radiotherapy-induced oral mucositis, which may be related to the improvement of salivary gland function and regulation of the oral microenvironment. Dendrobium officinale may reduce the symptoms of radiotherapy-induced oral mucositis by affecting the systemic cellular immune function. It may reduce the secretion of pro-inflammatory factors of the relevant flora by directly changing the oral flora and regulating the oral micro-ecology.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251313524"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11733883/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1177/15347354241308858
Nabil M Selim, Seham S El-Hawary, Soheir M El Zalabani, Rehab Nabil Shamma, Nariman El Sayed Mahdy, Noheir H Sherif, Khayrya A Youssif, Usama Ramadan Abdelmohsen, Mai H Mekkawy, Hanan A Fahmy
Objectives: Hepatocellular carcinoma (HCC) represents the third-most prevalent cancer in humans worldwide. The current study's objective is to search for the potentiality of Washingtonia robusta H. Wendl (W. robusta) leaf extract in a nanoemulsion (NE) form in enhancing radiotherapy against HCC induced in rats using diethylnitrosamine (DEN).
Material and methods: The metabolic composition of the bioactive extract of W. robusta leaves was investigated by LC-MS. Oral epithelial (OEC) and liver carcinoma (HepG2) cell lines were used to examine the safety and anticancer activity of the NE, respectively. In the in vivo study, HCC was induced in male albino rats through administration of DEN in drinking water for 8 weeks, then treatment with NE (100 mg/kg) until the experiment's ending. Rats were irradiated by a fractionated dose of 2Gy*4.
Results: NE exerted remarkable cytotoxicity in comparison to the parent extract and the standard doxorubicin on the HepG2 cell line. Besides, the NE administration and/or γ-irradiation (IRR) significantly reduced the elevated alanine aminotransferase (ALT), total proteins, and albumin levels in HCC-induced rats. Likewise, the tumor markers alpha-fetoprotein (AFP) and gamma-glutamyl transferase (GGT) levels were considerably reduced in HCC rats. In addition, NE treatment before IRR significantly decreased the expression of the poly ADP ribose polymerase-1 (PARP1) enzyme and Ki67. Furthermore, the histological investigations strongly confirmed the combined effect of NE and IRR in fighting DEN-induced HCC.
Conclusion: NE of W. robusta extract may possess a radiosensitizing novel impact and provide a new strategy to combat HCC in clinical practices.
{"title":"<i>Washingtonia robusta</i> H. Wendl Leaf Metabolites Potentiate the Radiosensitivity of Hepatocellular Carcinoma Through Ki67 and PARP Inhibition.","authors":"Nabil M Selim, Seham S El-Hawary, Soheir M El Zalabani, Rehab Nabil Shamma, Nariman El Sayed Mahdy, Noheir H Sherif, Khayrya A Youssif, Usama Ramadan Abdelmohsen, Mai H Mekkawy, Hanan A Fahmy","doi":"10.1177/15347354241308858","DOIUrl":"10.1177/15347354241308858","url":null,"abstract":"<p><strong>Objectives: </strong>Hepatocellular carcinoma (HCC) represents the third-most prevalent cancer in humans worldwide. The current study's objective is to search for the potentiality of <i>Washingtonia robusta</i> H. Wendl (<i>W. robusta</i>) leaf extract in a nanoemulsion (NE) form in enhancing radiotherapy against HCC induced in rats using diethylnitrosamine (DEN).</p><p><strong>Material and methods: </strong>The metabolic composition of the bioactive extract of <i>W. robusta</i> leaves was investigated by LC-MS. Oral epithelial (OEC) and liver carcinoma (HepG2) cell lines were used to examine the safety and anticancer activity of the NE, respectively. In the in vivo study, HCC was induced in male albino rats through administration of DEN in drinking water for 8 weeks, then treatment with NE (100 mg/kg) until the experiment's ending. Rats were irradiated by a fractionated dose of 2Gy*4.</p><p><strong>Results: </strong>NE exerted remarkable cytotoxicity in comparison to the parent extract and the standard doxorubicin on the HepG2 cell line. Besides, the NE administration and/or γ-irradiation (IRR) significantly reduced the elevated alanine aminotransferase (ALT), total proteins, and albumin levels in HCC-induced rats. Likewise, the tumor markers alpha-fetoprotein (AFP) and gamma-glutamyl transferase (GGT) levels were considerably reduced in HCC rats. In addition, NE treatment before IRR significantly decreased the expression of the poly ADP ribose polymerase-1 <b>(</b>PARP1) enzyme and Ki67. Furthermore, the histological investigations strongly confirmed the combined effect of NE and IRR in fighting DEN-induced HCC.</p><p><strong>Conclusion: </strong>NE of <i>W. robusta</i> extract may possess a radiosensitizing novel impact and provide a new strategy to combat HCC in clinical practices.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354241308858"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773528/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1177/15347354251318759
Tian He, Yifan Zhang, Di Deng, Zhiwen Yang, Qi Zhu, Qianhui Sun, Tao Lu
Systematic treatment and cocktailed drug applications have become a paradigm shift for cancer therapy. This study aims to explore the highly potent herbal cocktail strategies and pharmacological mechanisms, by which herbal medicines are effective in cancer treatment. A total of 397 cases of clinically reported cancer treatments with pure herbs were scrutinized, and the herbal prescription rules were systematically analyzed. The core prescriptions and their pharmacological mechanisms were revealed. The results unveiled specific rules for effective herbal treatment of cancer, including boosting energy metabolism, inhibiting tumor proliferation, improving digestion and defecation, enhancing blood circulation, promoting gas exchange, and facilitating water and toxic substance metabolism. Pharmacologically, anti-cancer effects are achieved through the manipulation of PI3K-Akt, IL-17, HIF-1, VEGF, TNF, Wnt, and other pathways. Following this unfolded integrative prescription rule, herbal therapy demonstrated remarkable effects in clinical practices, from which a few representative cases are presented herein.
{"title":"Effective Herbal Cocktail Strategies and Mechanisms in Cancer Treatment.","authors":"Tian He, Yifan Zhang, Di Deng, Zhiwen Yang, Qi Zhu, Qianhui Sun, Tao Lu","doi":"10.1177/15347354251318759","DOIUrl":"10.1177/15347354251318759","url":null,"abstract":"<p><p>Systematic treatment and cocktailed drug applications have become a paradigm shift for cancer therapy. This study aims to explore the highly potent herbal cocktail strategies and pharmacological mechanisms, by which herbal medicines are effective in cancer treatment. A total of 397 cases of clinically reported cancer treatments with pure herbs were scrutinized, and the herbal prescription rules were systematically analyzed. The core prescriptions and their pharmacological mechanisms were revealed. The results unveiled specific rules for effective herbal treatment of cancer, including boosting energy metabolism, inhibiting tumor proliferation, improving digestion and defecation, enhancing blood circulation, promoting gas exchange, and facilitating water and toxic substance metabolism. Pharmacologically, anti-cancer effects are achieved through the manipulation of PI3K-Akt, IL-17, HIF-1, VEGF, TNF, Wnt, and other pathways. Following this unfolded integrative prescription rule, herbal therapy demonstrated remarkable effects in clinical practices, from which a few representative cases are presented herein.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251318759"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11829292/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1177/15347354251314499
Lu Li, Yecai Huang, Jun Yin, Peng Xu, Mei Lan, Churong Li, Yunxiang Qi, Ke Xu, Bosen Li, Yukun Luo, Qinghua Jiang, Shanshan Peng, Jinyi Lang, Mei Feng
Purpose: Radiotherapy-induced oral mucositis is the most common side effect in nasopharyngeal carcinoma (NPC) patients. We aimed to evaluate the efficacy and safety of Rabdosia rubescens drop pills in NPC patients with radiation-induced oral mucositis (RTOM).
Methods: The study involved 40 NPC patients who were given Rabdosia rubescens drop pills thrice daily from the start of radiation therapy. The study monitored the incidence and severity of oral mucositis and oral pain. The main outcomes measured were the occurrence rate of oral mucositis, grade 3 oral mucositis, oral pain assessment, and changes in immunological function, body weight, BMI, NRS2002, and albumin levels.
Results: In the study, 38 patients completed the treatment. The incidence rates of Grade 0 to 3 oral mucositis were 5.26%, 21.05%, 47.37%, and 26.32% respectively. Pain levels were mild (42.11%), moderate (13.16%), and severe (13.16%). The onset of Grade 1, 2, and 3 oral mucositis occurred at 18, 24, and 30 days respectively. Grade 3 oral mucositis was associated with body weight, BMI, NRS2002 score, and albumin levels. Post-treatment, there was a decrease in CD4+/CD8+, CD3+, and CD4+ immune cells, but an increase in CD8+ cells. Mild to moderate gastrointestinal adverse events were observed in 13.2% of patients.
Conclusion: Rabdosia rubescens drop pills administration can reduce the incidence and severity of radiotherapy induced oral mucositis. Our finding suggested a positive impact of Rabdosia rubescens drops pills upon administration to NPC patients.
{"title":"The Effect of Rabdosia rubescens on Radiotherapy-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients: A Phase II Clinical Study.","authors":"Lu Li, Yecai Huang, Jun Yin, Peng Xu, Mei Lan, Churong Li, Yunxiang Qi, Ke Xu, Bosen Li, Yukun Luo, Qinghua Jiang, Shanshan Peng, Jinyi Lang, Mei Feng","doi":"10.1177/15347354251314499","DOIUrl":"10.1177/15347354251314499","url":null,"abstract":"<p><strong>Purpose: </strong>Radiotherapy-induced oral mucositis is the most common side effect in nasopharyngeal carcinoma (NPC) patients. We aimed to evaluate the efficacy and safety of Rabdosia rubescens drop pills in NPC patients with radiation-induced oral mucositis (RTOM).</p><p><strong>Methods: </strong>The study involved 40 NPC patients who were given Rabdosia rubescens drop pills thrice daily from the start of radiation therapy. The study monitored the incidence and severity of oral mucositis and oral pain. The main outcomes measured were the occurrence rate of oral mucositis, grade 3 oral mucositis, oral pain assessment, and changes in immunological function, body weight, BMI, NRS2002, and albumin levels.</p><p><strong>Results: </strong>In the study, 38 patients completed the treatment. The incidence rates of Grade 0 to 3 oral mucositis were 5.26%, 21.05%, 47.37%, and 26.32% respectively. Pain levels were mild (42.11%), moderate (13.16%), and severe (13.16%). The onset of Grade 1, 2, and 3 oral mucositis occurred at 18, 24, and 30 days respectively. Grade 3 oral mucositis was associated with body weight, BMI, NRS2002 score, and albumin levels. Post-treatment, there was a decrease in CD4<sup>+</sup>/CD8<sup>+</sup>, CD3<sup>+</sup>, and CD4<sup>+</sup> immune cells, but an increase in CD8<sup>+</sup> cells. Mild to moderate gastrointestinal adverse events were observed in 13.2% of patients.</p><p><strong>Conclusion: </strong>Rabdosia rubescens drop pills administration can reduce the incidence and severity of radiotherapy induced oral mucositis. Our finding suggested a positive impact of Rabdosia rubescens drops pills upon administration to NPC patients.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251314499"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1177/15347354251313533
Luchang Cao, Zilin Wang, Xinmiao Wang, Guanghui Zhu, Ying Zhang, Jie Li
Background: The incidence and mortality of lung cancer is the highest among malignant tumors worldwide, and it seriously threatens human life and health. Surgery is the primary radical treatment for lung cancer. However, patients often experience discomfort, changes in social roles, economic pressures, and other postsurgical challenges. These factors frequently cause various psychological disorders such as anxiety and depression, significantly diminishing the quality of life and elevating the risks of recurrence, metastasis, and mortality. Therefore, effective strategies for mental function rehabilitation should be urgently developed. Traditional Chinese medicine can significantly improve psychological function and physical symptoms after lung cancer surgery, and prolong patient survival. However, its effectiveness for mental function rehabilitation after lung cancer surgery remains unclear. This study aimed to investigate the effects of Chinese medicine on mental function recovery after lung cancer surgery through a systematic review and meta-analysis.
Methods: This study will systematically search the following databases: PubMed, Cochrane Library, EMBASE, Web of Science, ClinicalTrials.gov, China National Knowledge Infrastructure, Wanfang database, VIP database, and Chinese BioMedical Literature database. Search for studies published from the inception of each database until April 22, 2024. This study will be limited to clinical randomized controlled trials (RCTs). The primary outcome will be depression or anxiety, as indicated by the scale score. Data analysis will be performed using RevMan 5. The Cochrane Risk of Bias Assessment Tool will be used to evaluate the quality of included studies. Finally, the quality of the evidence will be classified using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) System.
Results: This meta-analysis aims to offer comprehensive evidence of the effectiveness of traditional Chinese medicine in mental function rehabilitation after lung cancer surgery. The study will assess the quality of the reports and conduct a subgroup analysis based on various postoperative stages, intervention measures, intervention duration, and sex to gather more evidence to fill the gap in psychological function rehabilitation after lung cancer surgery. These data can be used to guide clinical practice and inform future studies. More importantly, the results of this study will provide evidence to support the development of expert consensus and clinical guidelines in the field of mental function rehabilitation after lung cancer surgery.
背景:肺癌是世界范围内发病率和死亡率最高的恶性肿瘤,严重威胁着人类的生命和健康。手术是肺癌的主要根治方法。然而,患者经常会经历不适、社会角色的变化、经济压力和其他术后挑战。这些因素经常引起各种心理障碍,如焦虑和抑郁,显著降低生活质量,增加复发、转移和死亡率的风险。因此,迫切需要制定有效的心理功能康复策略。中药能显著改善肺癌术后的心理功能和躯体症状,延长患者生存期。然而,其对肺癌手术后心理功能康复的效果尚不清楚。本研究旨在通过系统综述和荟萃分析,探讨中药对肺癌术后心理功能恢复的影响。方法:系统检索PubMed、Cochrane Library、EMBASE、Web of Science、ClinicalTrials.gov、中国国家知识基础设施、万方数据库、VIP数据库、中国生物医学文献数据库。检索从每个数据库建立到2024年4月22日发表的研究。本研究仅限于临床随机对照试验(RCTs)。主要结果将是抑郁或焦虑,如量表得分所示。数据分析将使用RevMan 5进行。Cochrane偏倚风险评估工具将用于评估纳入研究的质量。最后,证据的质量将使用分级建议评估、发展和评估(GRADE)系统进行分类。结果:本荟萃分析旨在为中医在肺癌术后心理功能康复中的有效性提供综合证据。本研究将对报告的质量进行评估,并根据术后各阶段、干预措施、干预时间、性别进行亚组分析,以收集更多证据,填补肺癌手术后心理功能康复的空白。这些数据可用于指导临床实践并为未来的研究提供信息。更重要的是,本研究结果将为肺癌术后心理功能康复领域的专家共识和临床指南的制定提供证据支持。
{"title":"Effectiveness of Traditional Chinese Medicine in Psychological Rehabilitation After Lung Cancer Surgery: Systematic Review and Meta-Analysis protocol.","authors":"Luchang Cao, Zilin Wang, Xinmiao Wang, Guanghui Zhu, Ying Zhang, Jie Li","doi":"10.1177/15347354251313533","DOIUrl":"10.1177/15347354251313533","url":null,"abstract":"<p><strong>Background: </strong>The incidence and mortality of lung cancer is the highest among malignant tumors worldwide, and it seriously threatens human life and health. Surgery is the primary radical treatment for lung cancer. However, patients often experience discomfort, changes in social roles, economic pressures, and other postsurgical challenges. These factors frequently cause various psychological disorders such as anxiety and depression, significantly diminishing the quality of life and elevating the risks of recurrence, metastasis, and mortality. Therefore, effective strategies for mental function rehabilitation should be urgently developed. Traditional Chinese medicine can significantly improve psychological function and physical symptoms after lung cancer surgery, and prolong patient survival. However, its effectiveness for mental function rehabilitation after lung cancer surgery remains unclear. This study aimed to investigate the effects of Chinese medicine on mental function recovery after lung cancer surgery through a systematic review and meta-analysis.</p><p><strong>Methods: </strong>This study will systematically search the following databases: PubMed, Cochrane Library, EMBASE, Web of Science, ClinicalTrials.gov, China National Knowledge Infrastructure, <i>Wanfang</i> database, VIP database, and Chinese BioMedical Literature database. Search for studies published from the inception of each database until April 22, 2024. This study will be limited to clinical randomized controlled trials (RCTs). The primary outcome will be depression or anxiety, as indicated by the scale score. Data analysis will be performed using RevMan 5. The Cochrane Risk of Bias Assessment Tool will be used to evaluate the quality of included studies. Finally, the quality of the evidence will be classified using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) System.</p><p><strong>Results: </strong>This meta-analysis aims to offer comprehensive evidence of the effectiveness of traditional Chinese medicine in mental function rehabilitation after lung cancer surgery. The study will assess the quality of the reports and conduct a subgroup analysis based on various postoperative stages, intervention measures, intervention duration, and sex to gather more evidence to fill the gap in psychological function rehabilitation after lung cancer surgery. These data can be used to guide clinical practice and inform future studies. More importantly, the results of this study will provide evidence to support the development of expert consensus and clinical guidelines in the field of mental function rehabilitation after lung cancer surgery.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251313533"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11726522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1177/15347354251319339
Eunbyul Cho, Jin-Mu Yi, Jaemoo Chun, Ho Jang, Seong Hoon Yoon, Seung Hyeun Lee, Seung Hun Jang, Dong Won Park, Seung Joon Kim, Sang-Won Um, Sung Yong Lee, Mi-Kyung Jeong
Background: Non-small cell lung cancer (NSCLC) exhibits low survival rates. Although immune checkpoint inhibitors (ICIs) have become first-line treatment for NSCLC, their limited response to ICI monotherapy has led to exploration of combination treatments. However, the high incidence of treatment-related adverse events associated with conventional drug combinations has highlighted the need for alternative herbal therapy. Bojungikki-tang (BJIKT), a traditional herbal medicine, has been used to treat gastrointestinal disorders and enhance immune function. Our preclinical studies have demonstrated that BJIKT combined with anti-PD-1 or anti-PD-L1 antibodies exhibits significant efficacy in suppressing tumor growth by modulating the immunosuppressive tumor microenvironment. Building on these preclinical findings, this study aims to evaluate the efficacy and safety of BJIKT with pembrolizumab combination therapy compared to pembrolizumab monotherapy in advanced NSCLC patients.
Methods: 70 individuals with stage IV NSCLC scheduled for first-line pembrolizumab monotherapy will be randomly assigned to intervention or control groups. The primary outcome will be progression-free survival, with secondary outcomes including disease control rate, overall survival, and quality of life assessment. Adverse events will be monitored for safety. This study will explore the synergistic mechanism of combinatorial therapy using immune profiling and multi-omics analysis, and the possibility for personalized integrative therapy based on cold-heat syndrome differentiation (SD) types in East Asian medicine.
Discussion: This study will provide novel evidence regarding survival outcomes, quality of life, and safety profiles of combined ICI and BJIKT therapy for advanced NSCLC. The exploratory data will contribute to tailoring treatments to immune-based SD types in NSCLC patients.
{"title":"Efficacy and Safety of Herbal Medicine Bojungikki-Tang in Combination with Pembrolizumab versus Pembrolizumab Monotherapy for Stage IV Non-Small Cell Lung Cancer: Study Protocol for a Randomized, Open-Label, Double-Arm, Multicenter Trial.","authors":"Eunbyul Cho, Jin-Mu Yi, Jaemoo Chun, Ho Jang, Seong Hoon Yoon, Seung Hyeun Lee, Seung Hun Jang, Dong Won Park, Seung Joon Kim, Sang-Won Um, Sung Yong Lee, Mi-Kyung Jeong","doi":"10.1177/15347354251319339","DOIUrl":"10.1177/15347354251319339","url":null,"abstract":"<p><strong>Background: </strong>Non-small cell lung cancer (NSCLC) exhibits low survival rates. Although immune checkpoint inhibitors (ICIs) have become first-line treatment for NSCLC, their limited response to ICI monotherapy has led to exploration of combination treatments. However, the high incidence of treatment-related adverse events associated with conventional drug combinations has highlighted the need for alternative herbal therapy. Bojungikki-tang (BJIKT), a traditional herbal medicine, has been used to treat gastrointestinal disorders and enhance immune function. Our preclinical studies have demonstrated that BJIKT combined with anti-PD-1 or anti-PD-L1 antibodies exhibits significant efficacy in suppressing tumor growth by modulating the immunosuppressive tumor microenvironment. Building on these preclinical findings, this study aims to evaluate the efficacy and safety of BJIKT with pembrolizumab combination therapy compared to pembrolizumab monotherapy in advanced NSCLC patients.</p><p><strong>Methods: </strong>70 individuals with stage IV NSCLC scheduled for first-line pembrolizumab monotherapy will be randomly assigned to intervention or control groups. The primary outcome will be progression-free survival, with secondary outcomes including disease control rate, overall survival, and quality of life assessment. Adverse events will be monitored for safety. This study will explore the synergistic mechanism of combinatorial therapy using immune profiling and multi-omics analysis, and the possibility for personalized integrative therapy based on cold-heat syndrome differentiation (SD) types in East Asian medicine.</p><p><strong>Discussion: </strong>This study will provide novel evidence regarding survival outcomes, quality of life, and safety profiles of combined ICI and BJIKT therapy for advanced NSCLC. The exploratory data will contribute to tailoring treatments to immune-based SD types in NSCLC patients.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251319339"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11847320/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}