Pub Date : 2024-01-01DOI: 10.1177/15347354241293197
Junaidah B Barnett, George C Wang, Wu Zeng, Ruth W Kimokoti, Teresa T Fung, Yuan H Chen, Jerry Kantor, Wei Wang, Michelle D Holmes
Introduction: The Radical Remission Multimodal Intervention (RRMI) was developed by Kelly A. Turner, PhD, after analyzing more than 1500 cases of cancer survivors experiencing radical remission (a.k.a. spontaneous regression) across all cancer types and extracting key lifestyle factors shared by these cancer survivors. The RRMI workshops provide instruction on these lifestyle factors to participants with cancer and give them tools to help navigate their cancer recovery journey. This pilot study aimed to evaluate the effect of the RRMI on the quality of life (QOL) of people with cancer. Methods: This was a pre-post outcome study. Data were collected, between January 2019 and January 2022, from 200 eligible adults of all cancer types, who attended the RRMI workshops (online and in-person). Participants were asked to complete questionnaires online, at baseline (i.e., before the intervention) and at month 1 and month 6 post-intervention. The RRMI workshops were led by certified Radical Remission health coaches. Participants completed the RRMI with personalized action plans for them to implement. The primary outcome QOL measure was the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). Mixed-effects regression models were used to examine differences in FACIT-Sp score between month 1 and baseline, as well as month 6 and baseline. Models controlled for baseline score, covariates (including age, ethnic group, and body mass index), timepoints (month 1 or 6), training type (online or in-person), adherence score, and interaction between timepoints and adherence score. Results: 92% of participants were women, 77% were Non-Hispanic White, 88% were living in the US, and 66.5% were not living alone. One-quarter had breast cancer. Mean age ± SD was 55.3 ± 11.5 years. Final mixed-effects model analyses showed a significant increase in FACIT-Sp score of 9.5 (95% confidence interval [CI]: 6.2-12.8) points at month 1 (P < .0001) and 9.7 (95% CI: 6.4-13.0) points at month 6 (P < .0001) compared with baseline, a 7.7% and 10.8% improvement, respectively. Conclusion: The RRMI was found to significantly improve the overall QOL of participants at month 1. This improvement was maintained at month 6 post-intervention. Our findings suggest that people with cancer can benefit from the RRMI.
{"title":"Effect of the Radical Remission Multimodal Intervention on Quality of Life of People with Cancer.","authors":"Junaidah B Barnett, George C Wang, Wu Zeng, Ruth W Kimokoti, Teresa T Fung, Yuan H Chen, Jerry Kantor, Wei Wang, Michelle D Holmes","doi":"10.1177/15347354241293197","DOIUrl":"10.1177/15347354241293197","url":null,"abstract":"<p><p><b>Introduction:</b> The Radical Remission Multimodal Intervention (RRMI) was developed by Kelly A. Turner, PhD, after analyzing more than 1500 cases of cancer survivors experiencing radical remission (a.k.a. spontaneous regression) across all cancer types and extracting key lifestyle factors shared by these cancer survivors. The RRMI workshops provide instruction on these lifestyle factors to participants with cancer and give them tools to help navigate their cancer recovery journey. This pilot study aimed to evaluate the effect of the RRMI on the quality of life (QOL) of people with cancer. <b>Methods:</b> This was a pre-post outcome study. Data were collected, between January 2019 and January 2022, from 200 eligible adults of all cancer types, who attended the RRMI workshops (online and in-person). Participants were asked to complete questionnaires online, at baseline (i.e., before the intervention) and at month 1 and month 6 post-intervention. The RRMI workshops were led by certified Radical Remission health coaches. Participants completed the RRMI with personalized action plans for them to implement. The primary outcome QOL measure was the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). Mixed-effects regression models were used to examine differences in FACIT-Sp score between month 1 and baseline, as well as month 6 and baseline. Models controlled for baseline score, covariates (including age, ethnic group, and body mass index), timepoints (month 1 or 6), training type (online or in-person), adherence score, and interaction between timepoints and adherence score. <b>Results:</b> 92% of participants were women, 77% were Non-Hispanic White, 88% were living in the US, and 66.5% were not living alone. One-quarter had breast cancer. Mean age ± SD was 55.3 ± 11.5 years. Final mixed-effects model analyses showed a significant increase in FACIT-Sp score of 9.5 (95% confidence interval [CI]: 6.2-12.8) points at month 1 (<i>P</i> < .0001) and 9.7 (95% CI: 6.4-13.0) points at month 6 (<i>P</i> < .0001) compared with baseline, a 7.7% and 10.8% improvement, respectively. <b>Conclusion:</b> The RRMI was found to significantly improve the overall QOL of participants at month 1. This improvement was maintained at month 6 post-intervention. Our findings suggest that people with cancer can benefit from the RRMI.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354241293197"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545289","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 : 2024-01-01DOI: 10.1177/15347354241261373
Kirin Saint, Tina Paul, Clare Patterson, Mingxiao Yang, Ting Bao, Mary Lou Galantino
Background: Yoga interventions need fidelity monitoring to standardize the trial process and ensure adherence. We examined fidelity measures of current yoga trials and developed a fidelity assurance process in a phase III randomized clinical trial addressing chemotherapy-induced peripheral neuropathy among cancer survivors.
Methods: We qualitatively analyzed the fidelity monitoring components in published clinical trials on yoga therapy for chemotherapy-induced peripheral neuropathy through a literature search in PubMed from inception to February 2023. Leveraging fidelity measures for community-based, complex interventions and yoga therapy reporting guidelines, we developed an instructor/participant-oriented fidelity checking approach in an ongoing phase III trial evaluating yoga for improving chemotherapy-induced peripheral neuropathy in cancer survivors. Two researchers independently assessed 4 of 8 video recordings of yoga instructor-led training sessions (50%) and participant-kept home practice logs using a developed fidelity checklist.
Results: None of the 4 eligible yoga trials specifically have intervention fidelity measures. We prospectively incorporated yoga instructor training, virtual delivery, and participant engagement strategies in the phase III trial protocol following guidelines. All trial yoga instructors were trained under study protocol to ensure compliance and participant engagement. There was high intervention fidelity in all instructor-led virtual sessions: an average of 100% adherence to class structure and three-thirds on specific skills. Assessment of participant adherence to the established home yoga protocol was 63%.
Conclusion: Yoga trials for chemotherapy-induced peripheral neuropathy need adequate fidelity measures. Our study provides a feasible fidelity-monitoring approach to ensure trial intervention delivery and protocol adherence by instructors and participants in oncological settings.
背景:瑜伽干预措施需要保真度监控,以规范试验过程并确保坚持。我们研究了当前瑜伽试验的忠实性措施,并在一项针对癌症幸存者化疗引起的周围神经病变的 III 期随机临床试验中制定了忠实性保证流程:我们通过在PubMed上搜索从开始到2023年2月的文献,定性分析了已发表的瑜伽疗法治疗化疗引起的周围神经病变的临床试验中的保真度监测内容。利用基于社区的复杂干预措施的忠实性测量方法和瑜伽疗法报告指南,我们在一项正在进行的III期试验中开发了一种以指导者/参与者为导向的忠实性检查方法,该试验评估了瑜伽改善癌症幸存者化疗引起的周围神经病变的效果。两名研究人员使用开发的忠实性检查表独立评估了 8 个瑜伽教练指导的培训课程录像中的 4 个(50%)以及参与者保存的家庭练习日志:结果:符合条件的 4 项瑜伽试验中没有一项专门针对干预的忠实性措施。我们根据指南,将瑜伽指导员培训、虚拟授课和参与者参与策略前瞻性地纳入了 III 期试验方案。所有试验的瑜伽指导员都根据研究方案接受了培训,以确保符合要求和参与者的参与。在所有由教练指导的虚拟课程中,干预的忠实度都很高:对课堂结构的遵守率平均为 100%,对特定技能的遵守率平均为三分之二。参与者对既定家庭瑜伽方案的依从性评估为 63%:结论:针对化疗引起的周围神经病变的瑜伽试验需要足够的保真度措施。我们的研究提供了一种可行的保真度监控方法,以确保在肿瘤环境中进行试验干预时,指导者和参与者都能遵守协议。
{"title":"Assessing Fidelity in Yoga Interventions for Chemotherapy-Induced Peripheral Neuropathy: Decision-Making to Enhance Protocol Quality Adherence.","authors":"Kirin Saint, Tina Paul, Clare Patterson, Mingxiao Yang, Ting Bao, Mary Lou Galantino","doi":"10.1177/15347354241261373","DOIUrl":"10.1177/15347354241261373","url":null,"abstract":"<p><strong>Background: </strong>Yoga interventions need fidelity monitoring to standardize the trial process and ensure adherence. We examined fidelity measures of current yoga trials and developed a fidelity assurance process in a phase III randomized clinical trial addressing chemotherapy-induced peripheral neuropathy among cancer survivors.</p><p><strong>Methods: </strong>We qualitatively analyzed the fidelity monitoring components in published clinical trials on yoga therapy for chemotherapy-induced peripheral neuropathy through a literature search in PubMed from inception to February 2023. Leveraging fidelity measures for community-based, complex interventions and yoga therapy reporting guidelines, we developed an instructor/participant-oriented fidelity checking approach in an ongoing phase III trial evaluating yoga for improving chemotherapy-induced peripheral neuropathy in cancer survivors. Two researchers independently assessed 4 of 8 video recordings of yoga instructor-led training sessions (50%) and participant-kept home practice logs using a developed fidelity checklist.</p><p><strong>Results: </strong>None of the 4 eligible yoga trials specifically have intervention fidelity measures. We prospectively incorporated yoga instructor training, virtual delivery, and participant engagement strategies in the phase III trial protocol following guidelines. All trial yoga instructors were trained under study protocol to ensure compliance and participant engagement. There was high intervention fidelity in all instructor-led virtual sessions: an average of 100% adherence to class structure and three-thirds on specific skills. Assessment of participant adherence to the established home yoga protocol was 63%.</p><p><strong>Conclusion: </strong>Yoga trials for chemotherapy-induced peripheral neuropathy need adequate fidelity measures. Our study provides a feasible fidelity-monitoring approach to ensure trial intervention delivery and protocol adherence by instructors and participants in oncological settings.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354241261373"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11283657/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787929","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 : 2024-01-01DOI: 10.1177/15347354241294043
Tongfei Feng, Yanlin Zhou, Xiangying Mao, Xiaowei Rui, Lijun Cai
Background: Chemoresistance represented one of the challenges in the treatment of advanced gastric cancer (GC). Curcumol (CUR) was found to have a certain sensitizing effect on chemoresistance, although the mechanism was not yet fully understood. Purpose: To clarify the ability of CUR to intervene in the sensitivity of GC cells to Cisplatin (CDDP) by regulating the induction of ferroptosis through the P62/KEAP1/NRF2 pathway. Methods: An in vitro resistant cell line was established and treated with CUR for intervention. The synergy was evaluated using synergyfinder3.0 software. The impact of the combined use of CUR and CDDP on the proliferation, migration, and invasion of resistant GC cells was determined. The effect of CUR on ferroptosis in resistant GC cell lines was evaluated by measuring changes in reactive oxygen species (ROS) levels, malondialdehyde (MDA) levels, iron ion levels, and the ratio of reduced glutathione (GSH) to oxidized glutathione (GSSG). Western blotting was used to verify the expression changes of the ferroptosis-related indicator GPX4 and the differential expression of the antioxidant-related pathway P62/KEAP1/NRF2, validating the mechanism by which CUR induces ferroptosis in resistant GC cells. In vivo validation was performed using a xenograft mouse model. Results: The evaluation by synergy3.0 revealed a synergistic effect between CUR and CDDP. After treatment with CUR and CDDP, resistant GC cell lines exhibited reduced proliferation, migration, and invasion capabilities. Furthermore, the resistant GC cell lines underwent ferroptosis, with significant changes observed in ferroptosis-related indicators such as ROS, MDA, iron ions, and GSH/GSSG. The ferroptosis-related targets Glutathione Peroxidase 4 (GPX4) and the antioxidant pathway P62/KEAP1/NRF2 signaling pathway also showed significant changes. In in vivo validation, the combination of CUR and CDDP inhibited the growth of subcutaneous tumors and was found to be associated with the inhibition of subcutaneous xenografts and the GPX4 and P62/KEAP1/NRF2 signaling pathways. Conclusion: This study first revealed that CUR enhanced the sensitivity of cisplatin-resistant GC cells to CDDP by inducing ferroptosis. The combination of CUR and CDDP induces ferroptosis in cisplatin-resistant GC through the P62/KEAP1/NRF2 pathway.
背景:化疗耐药性是晚期胃癌(GC)治疗过程中面临的挑战之一。研究发现莪术醇(CUR)对化疗耐药性有一定的增敏作用,但其机制尚未完全明了。目的:阐明莪术醇通过 P62/KEAP1/NRF2 通路调节铁变态反应的诱导,从而干预 GC 细胞对顺铂 (CDDP) 的敏感性。研究方法建立体外耐药细胞系并用 CUR 进行干预。使用 synergyfinder3.0 软件评估协同作用。确定了联合使用 CUR 和 CDDP 对耐药 GC 细胞的增殖、迁移和侵袭的影响。通过测量活性氧(ROS)水平、丙二醛(MDA)水平、铁离子水平以及还原型谷胱甘肽(GSH)与氧化型谷胱甘肽(GSSG)之比的变化,评估了 CUR 对耐药性 GC 细胞株铁变态反应的影响。利用 Western 印迹技术验证了铁变态反应相关指标 GPX4 的表达变化以及抗氧化相关途径 P62/KEAP1/NRF2 的差异表达,从而验证了 CUR 在耐药性 GC 细胞中诱导铁变态反应的机制。利用异种移植小鼠模型进行了体内验证。结果:synergy3.0 评估显示,CUR 和 CDDP 具有协同效应。经 CUR 和 CDDP 处理后,耐药 GC 细胞株的增殖、迁移和侵袭能力均有所下降。此外,耐药 GC 细胞株发生了铁变态反应,与铁变态反应相关的指标,如 ROS、MDA、铁离子和 GSH/GSSG 都发生了显著变化。与铁变态反应相关的靶点谷胱甘肽过氧化物酶4(GPX4)和抗氧化通路P62/KEAP1/NRF2信号通路也发生了显著变化。在体内验证中,CUR 和 CDDP 的组合抑制了皮下肿瘤的生长,并发现这与抑制皮下异种移植以及 GPX4 和 P62/KEAP1/NRF2 信号通路有关。结论本研究首次发现 CUR 通过诱导铁变态反应增强了顺铂耐药 GC 细胞对 CDDP 的敏感性。CUR和CDDP联合使用可通过P62/KEAP1/NRF2途径诱导顺铂耐药GC的铁突变。
{"title":"Curcumol Enhances the Sensitivity of Gastric Cancer to Cisplatin Resistance by Inducing Ferroptosis Through the P62/KEAP1/NRF2 Pathway.","authors":"Tongfei Feng, Yanlin Zhou, Xiangying Mao, Xiaowei Rui, Lijun Cai","doi":"10.1177/15347354241294043","DOIUrl":"10.1177/15347354241294043","url":null,"abstract":"<p><p><b>Background:</b> Chemoresistance represented one of the challenges in the treatment of advanced gastric cancer (GC). Curcumol (CUR) was found to have a certain sensitizing effect on chemoresistance, although the mechanism was not yet fully understood. <b>Purpose:</b> To clarify the ability of CUR to intervene in the sensitivity of GC cells to Cisplatin (CDDP) by regulating the induction of ferroptosis through the P62/KEAP1/NRF2 pathway. <b>Methods:</b> An in vitro resistant cell line was established and treated with CUR for intervention. The synergy was evaluated using synergyfinder3.0 software. The impact of the combined use of CUR and CDDP on the proliferation, migration, and invasion of resistant GC cells was determined. The effect of CUR on ferroptosis in resistant GC cell lines was evaluated by measuring changes in reactive oxygen species (ROS) levels, malondialdehyde (MDA) levels, iron ion levels, and the ratio of reduced glutathione (GSH) to oxidized glutathione (GSSG). Western blotting was used to verify the expression changes of the ferroptosis-related indicator GPX4 and the differential expression of the antioxidant-related pathway P62/KEAP1/NRF2, validating the mechanism by which CUR induces ferroptosis in resistant GC cells. In vivo validation was performed using a xenograft mouse model. <b>Results:</b> The evaluation by synergy3.0 revealed a synergistic effect between CUR and CDDP. After treatment with CUR and CDDP, resistant GC cell lines exhibited reduced proliferation, migration, and invasion capabilities. Furthermore, the resistant GC cell lines underwent ferroptosis, with significant changes observed in ferroptosis-related indicators such as ROS, MDA, iron ions, and GSH/GSSG. The ferroptosis-related targets Glutathione Peroxidase 4 (GPX4) and the antioxidant pathway P62/KEAP1/NRF2 signaling pathway also showed significant changes. In in vivo validation, the combination of CUR and CDDP inhibited the growth of subcutaneous tumors and was found to be associated with the inhibition of subcutaneous xenografts and the GPX4 and P62/KEAP1/NRF2 signaling pathways. <b>Conclusion:</b> This study first revealed that CUR enhanced the sensitivity of cisplatin-resistant GC cells to CDDP by inducing ferroptosis. The combination of CUR and CDDP induces ferroptosis in cisplatin-resistant GC through the P62/KEAP1/NRF2 pathway.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354241294043"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11544674/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604448","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 : 2024-01-01DOI: 10.1177/15347354241263018
Chen Jiayi, Chen Siru, Luo Xiaoqi, Xu Enling, Wu Hui, Lin Juze, Wang Changjun
Objective: The Chinese medicine Jianpi-Huayu decoction (, JPHY) can alleviate cancer-related fatigue in patients with liver cancer. However, its mechanism remains unclear. In this study, we used BALB/c mice with liver cancer model to investigate whether JPHY alleviates cancer-related fatigue by regulating Th1/Th2 immune balance; and the possible association with the IL-27/STAT1 signaling pathway. Methods: We established a mouse model of liver cancer fatigue. Mice were gavaged with physiological saline, low, medium, or high concentrations of JPHY respectively; and intraperitoneal injection of fludarabine (STAT1 pathway inhibitor) with JPHY for 21 days. We recorded the general condition of the mice, and assessed fatigue using scoring criteria and Exhausted Swimming Test. We calculated the spleen and thymus indices, performed H&E staining and immunohistochemical analysis on liver tumor tissues to observe the tumor proliferation marker ki67. We quantified the secretion levels of IFN-γ and IL-2 produced by Th1 cells in serum and splenic lymphocytes, as well as the secretion of IL-4, IL-10 by Th2 cells, and IL-27 in the signaling pathway through ELISA analysis. We evaluated the expression levels of p-STAT1 and STAT1 in spleen tissues using Western blot analysis. Results: JPHY exhibits a therapeutic effect on hepatocellular carcinoma-induced splenomegaly in murine models by upregulating the pro-inflammatory cytokines IFN-γ and IL-2 and downregulating the anti-inflammatory cytokines IL-4 and IL-10. Moreover, JPHY suppresses ki67 expression, reduces tumor-related inflammation infiltration, and ameliorates cancer-associated fatigue. Additionally, the expression of phosphorylated protein p-STAT1 is down-regulated. Conclusion: JPHY may improve the Th1/Th2 immune balance through its anti-inflammatory effects and promotion of IL-27-induced STAT1 phosphorylation, thereby alleviating fatigue in mice with liver cancer.
{"title":"Effects of Jianpi Huayu Decoction on Th1/Th2 Immune Balance in Mice With Liver Cancer-Related Fatigue via the IL- 27/STAT1 Signaling Pathway.","authors":"Chen Jiayi, Chen Siru, Luo Xiaoqi, Xu Enling, Wu Hui, Lin Juze, Wang Changjun","doi":"10.1177/15347354241263018","DOIUrl":"10.1177/15347354241263018","url":null,"abstract":"<p><p><b>Objective:</b> The Chinese medicine Jianpi-Huayu decoction (, JPHY) can alleviate cancer-related fatigue in patients with liver cancer. However, its mechanism remains unclear. In this study, we used BALB/c mice with liver cancer model to investigate whether JPHY alleviates cancer-related fatigue by regulating Th1/Th2 immune balance; and the possible association with the IL-27/STAT1 signaling pathway. <b>Methods:</b> We established a mouse model of liver cancer fatigue. Mice were gavaged with physiological saline, low, medium, or high concentrations of JPHY respectively; and intraperitoneal injection of fludarabine (STAT1 pathway inhibitor) with JPHY for 21 days. We recorded the general condition of the mice, and assessed fatigue using scoring criteria and Exhausted Swimming Test. We calculated the spleen and thymus indices, performed H&E staining and immunohistochemical analysis on liver tumor tissues to observe the tumor proliferation marker ki67. We quantified the secretion levels of IFN-γ and IL-2 produced by Th1 cells in serum and splenic lymphocytes, as well as the secretion of IL-4, IL-10 by Th2 cells, and IL-27 in the signaling pathway through ELISA analysis. We evaluated the expression levels of p-STAT1 and STAT1 in spleen tissues using Western blot analysis. <b>Results:</b> JPHY exhibits a therapeutic effect on hepatocellular carcinoma-induced splenomegaly in murine models by upregulating the pro-inflammatory cytokines IFN-γ and IL-2 and downregulating the anti-inflammatory cytokines IL-4 and IL-10. Moreover, JPHY suppresses ki67 expression, reduces tumor-related inflammation infiltration, and ameliorates cancer-associated fatigue. Additionally, the expression of phosphorylated protein p-STAT1 is down-regulated. <b>Conclusion:</b> JPHY may improve the Th1/Th2 immune balance through its anti-inflammatory effects and promotion of IL-27-induced STAT1 phosphorylation, thereby alleviating fatigue in mice with liver cancer.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354241263018"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11289807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792420","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 : 2024-01-01DOI: 10.1177/15347354231226115
Lib Ahn, Song Won Park, Dong-Jun Choi
Chemotherapy-induced leukopenia is a common side effect of cytotoxic anticancer drugs. It can deprive patients of treatment opportunities, resulting in the delay, reduction, or discontinuation of chemotherapy or other anticancer drug administration. Two researchers searched English, Chinese, Japanese, and Korean electronic databases, without limiting the time period and language, using search terms such as "Bojungikgi," "WBC," "leuko," and "neutrop." Among the human randomized controlled studies in which Bojungikgi-tang was administered to patients who underwent chemotherapy, studies reporting leukopenia-related outcomes were selected, and data extraction, bias risk assessment, and meta-analysis were performed on the selected papers. Ten studies were selected, and a systematic review with meta-analysis was conducted. Nine papers were published in China and the total number of participants was 715. As a result of administering Bojungikgi-tang to these patients, the number of patients with chemotherapy-induced leukopenia significantly decreased (OR: 0.41, 95% CI: 0.27-0.61, P = .0001, I2 = 35%). Further, white blood cell counts were compared with that of the control group, and it showed an effect on prevention (MD: 0.64, 95% CI: 0.46-0.83, P < .00001, I2 = 90%). A pronounced effect was observed, especially when administered after a diagnosis based on the pattern identification, such as Qi deficiency. (OR: 0.32, 95% CI: 0.18-0.58, P = .0002, I2 = 0%). However, all studies had a high risk of bias due to non-blinding, and most studies had a high or uncertain risk of bias in creating random assignment orders and concealing them. Bojungikgi-tang has an effect on the prevention and treatment of chemotherapy-induced leukopenia. The effect rate can be increased when administered after proper diagnosis, and the possibility of adverse reactions and side effects is lower than that of Granulocyte-Colony Stimulating Factor (G-CSF) injection. Bojungikgi-tang appears to be useful in the treatment and prevention of leukopenia caused by cytotoxic anticancer drugs. However, it is necessary to conduct high-quality clinical studies in the future, considering the possibility of local and language bias, heterogeneity of carcinoma and intervention, and the risk of bias.Registration: PROSPERO CRD4202341054.
{"title":"Bojungikgi-tang for Chemotherapy-induced Leukopenia: A Systematic Review and Meta-Analysis.","authors":"Lib Ahn, Song Won Park, Dong-Jun Choi","doi":"10.1177/15347354231226115","DOIUrl":"10.1177/15347354231226115","url":null,"abstract":"<p><p>Chemotherapy-induced leukopenia is a common side effect of cytotoxic anticancer drugs. It can deprive patients of treatment opportunities, resulting in the delay, reduction, or discontinuation of chemotherapy or other anticancer drug administration. Two researchers searched English, Chinese, Japanese, and Korean electronic databases, without limiting the time period and language, using search terms such as \"Bojungikgi,\" \"WBC,\" \"leuko,\" and \"neutrop.\" Among the human randomized controlled studies in which Bojungikgi-tang was administered to patients who underwent chemotherapy, studies reporting leukopenia-related outcomes were selected, and data extraction, bias risk assessment, and meta-analysis were performed on the selected papers. Ten studies were selected, and a systematic review with meta-analysis was conducted. Nine papers were published in China and the total number of participants was 715. As a result of administering Bojungikgi-tang to these patients, the number of patients with chemotherapy-induced leukopenia significantly decreased (OR: 0.41, 95% CI: 0.27-0.61, <i>P</i> = .0001, <i>I</i><sup>2</sup> = 35%). Further, white blood cell counts were compared with that of the control group, and it showed an effect on prevention (MD: 0.64, 95% CI: 0.46-0.83, <i>P</i> < .00001, <i>I</i><sup>2</sup> = 90%). A pronounced effect was observed, especially when administered after a diagnosis based on the pattern identification, such as Qi deficiency. (OR: 0.32, 95% CI: 0.18-0.58, <i>P</i> = .0002, <i>I</i><sup>2</sup> = 0%). However, all studies had a high risk of bias due to non-blinding, and most studies had a high or uncertain risk of bias in creating random assignment orders and concealing them. Bojungikgi-tang has an effect on the prevention and treatment of chemotherapy-induced leukopenia. The effect rate can be increased when administered after proper diagnosis, and the possibility of adverse reactions and side effects is lower than that of Granulocyte-Colony Stimulating Factor (G-CSF) injection. Bojungikgi-tang appears to be useful in the treatment and prevention of leukopenia caused by cytotoxic anticancer drugs. However, it is necessary to conduct high-quality clinical studies in the future, considering the possibility of local and language bias, heterogeneity of carcinoma and intervention, and the risk of bias.Registration: PROSPERO CRD4202341054.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354231226115"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10909318/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140012486","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 : 2024-01-01DOI: 10.1177/15347354241259180
Zhang Mengqin, Liu Xing, Huang Yan, Ren Jianhua
Background: Women with gynecological cancer often experience psychological distress, particularly in response to surgical procedures. The impact of mandala art therapy (MAT) during the perioperative period for gynecological cancer patients remains uncertain. We aimed to examine the effects of the MAT program in women with gynecological cancer.
Methods: Employing a quasi-experimental design, we recruited 126 gynecological cancer patients from a university hospital through convenience sampling. Participants were assigned to either receive the MAT program or standard perioperative care. The interventions comprised a three-session MAT program guided by a team of trained mandala psychologists. Generalized estimating equations (GEE) were employed to analyze the effects of MAT over time.
Results: A total of 126 patients were enrolled, and 118 completed the entire study. Over 90% of participants completed the perioperative MAT interventions, reporting relatively high satisfaction with the program (7.70 out of 10). Individuals in the MAT group exhibited improved therapeutic effects on STAI-S, VASS, and vital signs over time. Notably, significant group*time interaction effects were noted in STAI-S scores at both the first evaluation, T1 (β = -4.220, P < .005) and the third evaluation, T3 (β = -3.797, P < .05), and VASS scores at T1 (β = -11.186, P < .005), T2 (β = -9.915, P < .05) and T3 (β = -9.831, P < .05). Regarding vital signs, the multivariate GEE model revealed significant interaction effects in systolic blood pressure values at both T1 (β = -7.102, P < .05) and T3 (β = -10.051, P < .005), diastolic blood pressure values at T3 (β = -6.441, P < .005), and pulse values at T1 (β = -6.085, P < .005). No significant differences were observed between groups for pain, hope, or self-acceptance.
Conclusion: This study posited that MAT could serve as a valuable complementary approach in perioperative care for addressing the psychological needs of women with gynecological cancer. Subsequent research employing more robust methodologies and larger, more diverse participant samples will be necessary to validate these conclusions.
背景:罹患妇科癌症的女性经常会遇到心理困扰,尤其是在手术过程中。曼陀罗艺术疗法(MAT)对妇科癌症患者围手术期的影响仍不确定。我们旨在研究曼陀罗艺术疗法对妇科癌症女性患者的影响:我们采用准实验设计,通过便利抽样从一家大学医院招募了 126 名妇科癌症患者。参与者被分配接受 MAT 计划或标准围手术期护理。干预措施包括由训练有素的曼陀罗心理学家团队指导的为期三节的 MAT 计划。采用广义估计方程(GEE)分析 MAT 随时间推移产生的效果:共有 126 名患者报名参加,其中 118 人完成了整个研究。超过 90% 的参与者完成了围手术期 MAT 干预,并对该项目表示出较高的满意度(7.70 分,满分为 10 分)。随着时间的推移,MAT 组患者在 STAI-S、VASS 和生命体征方面的治疗效果有所改善。值得注意的是,在第一次评估(T1)时,STAI-S 分数都出现了明显的组别*时间交互效应(β = -4.220, P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P 结论:本研究认为,MAT 可以作为围手术期护理的一种有价值的补充方法,以满足妇科癌症妇女的心理需求。为了验证这些结论,有必要采用更可靠的方法和更大规模、更多样化的参与者样本进行后续研究。
{"title":"Does Mandala Art Therapy Improve Psychological Well-Being of Gynecological Cancer Patients During the Perioperative Period? A Quasi-Experimental Study.","authors":"Zhang Mengqin, Liu Xing, Huang Yan, Ren Jianhua","doi":"10.1177/15347354241259180","DOIUrl":"10.1177/15347354241259180","url":null,"abstract":"<p><strong>Background: </strong>Women with gynecological cancer often experience psychological distress, particularly in response to surgical procedures. The impact of mandala art therapy (MAT) during the perioperative period for gynecological cancer patients remains uncertain. We aimed to examine the effects of the MAT program in women with gynecological cancer.</p><p><strong>Methods: </strong>Employing a quasi-experimental design, we recruited 126 gynecological cancer patients from a university hospital through convenience sampling. Participants were assigned to either receive the MAT program or standard perioperative care. The interventions comprised a three-session MAT program guided by a team of trained mandala psychologists. Generalized estimating equations (GEE) were employed to analyze the effects of MAT over time.</p><p><strong>Results: </strong>A total of 126 patients were enrolled, and 118 completed the entire study. Over 90% of participants completed the perioperative MAT interventions, reporting relatively high satisfaction with the program (7.70 out of 10). Individuals in the MAT group exhibited improved therapeutic effects on STAI-S, VASS, and vital signs over time. Notably, significant group*time interaction effects were noted in STAI-S scores at both the first evaluation, T1 (β = -4.220, <i>P</i> < .005) and the third evaluation, T3 (β = -3.797, <i>P</i> < .05), and VASS scores at T1 (β = -11.186, <i>P</i> < .005), T2 (β = -9.915, <i>P</i> < .05) and T3 (β = -9.831, <i>P</i> < .05). Regarding vital signs, the multivariate GEE model revealed significant interaction effects in systolic blood pressure values at both T1 (β = -7.102, <i>P</i> < .05) and T3 (β = -10.051, <i>P</i> < .005), diastolic blood pressure values at T3 (β = -6.441, <i>P</i> < .005), and pulse values at T1 (β = -6.085, <i>P</i> < .005). No significant differences were observed between groups for pain, hope, or self-acceptance.</p><p><strong>Conclusion: </strong>This study posited that MAT could serve as a valuable complementary approach in perioperative care for addressing the psychological needs of women with gynecological cancer. Subsequent research employing more robust methodologies and larger, more diverse participant samples will be necessary to validate these conclusions.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354241259180"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11159551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141283672","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 : 2024-01-01DOI: 10.1177/15347354241295269
Chunxia He, Liuning Li, Bing Feng, Liqian Xie, Liwen Zhang, Bai Liu
Concurrent chemoradiotherapy (CCRT) represents the established therapeutic modality for managing locally advanced non-small cell lung cancer (LA-NSCLC). However, its impact on improving the poor prognosis of LA-NSCLC patients is limited, and it can cause severe side effects. A 62-year-old Chinese female was diagnosed with unresectable stage IIIA lung adenocarcinoma. She refused CCRT. Enhanced computed tomography of the chest revealed a space-occupying lesion in her left pulmonary hilum, invading and encircling the pulmonary artery trunk. Due to the reported anti-tumor effects of basil, a stasis-removing Chinese herb, the patient received basil combined with cisplatin plus pemetrexed (CP) chemotherapy as first-line treatment. After 6 cycles of treatment, her condition achieved complete remission, and circulating tumor cells were reduced to zero. Regular follow-ups showed that the patient maintained progression-free survival for nearly 3 years. This case highlights the potential efficacy of basil combined with CP chemotherapy in treating LA-NSCLC. However, the curative effect of this regimen needs further validation through larger clinical trials.
{"title":"Complete Response of Locally Advanced Lung Adenocarcinoma Following Basil Combined With Cisplatin Plus Pemetrexed Chemotherapy: A Case Report.","authors":"Chunxia He, Liuning Li, Bing Feng, Liqian Xie, Liwen Zhang, Bai Liu","doi":"10.1177/15347354241295269","DOIUrl":"10.1177/15347354241295269","url":null,"abstract":"<p><p>Concurrent chemoradiotherapy (CCRT) represents the established therapeutic modality for managing locally advanced non-small cell lung cancer (LA-NSCLC). However, its impact on improving the poor prognosis of LA-NSCLC patients is limited, and it can cause severe side effects. A 62-year-old Chinese female was diagnosed with unresectable stage IIIA lung adenocarcinoma. She refused CCRT. Enhanced computed tomography of the chest revealed a space-occupying lesion in her left pulmonary hilum, invading and encircling the pulmonary artery trunk. Due to the reported anti-tumor effects of basil, a stasis-removing Chinese herb, the patient received basil combined with cisplatin plus pemetrexed (CP) chemotherapy as first-line treatment. After 6 cycles of treatment, her condition achieved complete remission, and circulating tumor cells were reduced to zero. Regular follow-ups showed that the patient maintained progression-free survival for nearly 3 years. This case highlights the potential efficacy of basil combined with CP chemotherapy in treating LA-NSCLC. However, the curative effect of this regimen needs further validation through larger clinical trials.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354241295269"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11544759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604445","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}
Gastrointestinal (GI) cancer stands as one of the most prevalent forms of cancer globally, presenting a substantial medical and economic burden on cancer treatment. Despite advancements in therapies, it continues to exhibit the second highest mortality rate, primarily attributed to drug resistance and post-treatment side effects. There is an urgent need for novel therapeutic approaches to tackle this persistent challenge. Scutellaria baicalensis, widely used in Traditional Chinese Medicine (TCM), holds a profound pharmaceutical legacy. Modern pharmacological studies have unveiled its anticancer, antioxidant, and immune-enhancing properties. S. baicalensis contains hundreds of active ingredients, with flavonoids, polysaccharides, phenylethanoid glycosides, terpenoids, and sterols being the principal components. These constituents contribute to the treatment of GI cancer by inducing apoptosis in tumor cells, arresting the cell cycle, inhibiting tumor proliferation and metastasis, regulating the tumor microenvironment, modulating epigenetics, and reversing drug resistance. Furthermore, the utilization of modern drug delivery technologies can enhance the bioavailability and therapeutic efficacy of TCM. The treatment of GI cancer with S. baicalensis is characterized by its multi-component, multi-target, and multi-pathway advantages, and S. baicalensis has a broad prospect of becoming a clinical adjuvant or even the main therapy for GI cancer.
{"title":"Research Progress of <i>Scutellaria baicalensis</i> in the Treatment of Gastrointestinal Cancer.","authors":"Lankang Wang, Baoyi Ni, Jia Wang, Jilai Zhou, Junyi Wang, Jiakang Jiang, Yutong Sui, Yaoyao Tian, Feng Gao, Yufeng Lyu","doi":"10.1177/15347354241302049","DOIUrl":"10.1177/15347354241302049","url":null,"abstract":"<p><p>Gastrointestinal (GI) cancer stands as one of the most prevalent forms of cancer globally, presenting a substantial medical and economic burden on cancer treatment. Despite advancements in therapies, it continues to exhibit the second highest mortality rate, primarily attributed to drug resistance and post-treatment side effects. There is an urgent need for novel therapeutic approaches to tackle this persistent challenge. <i>Scutellaria baicalensis</i>, widely used in Traditional Chinese Medicine (TCM), holds a profound pharmaceutical legacy. Modern pharmacological studies have unveiled its anticancer, antioxidant, and immune-enhancing properties. <i>S. baicalensis</i> contains hundreds of active ingredients, with flavonoids, polysaccharides, phenylethanoid glycosides, terpenoids, and sterols being the principal components. These constituents contribute to the treatment of GI cancer by inducing apoptosis in tumor cells, arresting the cell cycle, inhibiting tumor proliferation and metastasis, regulating the tumor microenvironment, modulating epigenetics, and reversing drug resistance. Furthermore, the utilization of modern drug delivery technologies can enhance the bioavailability and therapeutic efficacy of TCM. The treatment of GI cancer with <i>S. baicalensis</i> is characterized by its multi-component, multi-target, and multi-pathway advantages, and <i>S. baicalensis</i> has a broad prospect of becoming a clinical adjuvant or even the main therapy for GI cancer.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354241302049"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750890","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}
Background: Sleep disturbance and insomnia are common adverse events in patients with breast cancer (BC). Traditional Chinese Medicine (TCM) treatment for sleep disturbance includes acupuncture, acupressure, auricular acupressure/auricular acupuncture, and Qigong. However, the specific efficacy of these TCM treatment remains unclear.
Materials and methods: This systematic review and network meta-analysis (NMA) investigated the effects of various TCM treatment on improving sleep quality in BC survivors.
Methods: Only randomized controlled trials (RCTs) reporting the results of TCM treatments were included. The main NMA included 12 RCTs involving 1011 participants. The risk of bias was assessed using the RoB 2 tool for randomized controlled trials. The certainty of evidence of the NMA was assessed in accordance with GRADE (the Grading of Recommendations, Assessment, Development, and Evaluations).
Results: Acupressure, acupuncture, auricular acupuncture/auricular acupressure, and qigong were identified as optimal TCM treatment (P < .05) for enhancing sleep quality in BC survivors.
Conclusion: Our results provide some evidence that TCM treatment, particularly acupressure, can be beneficial in improving sleep quality in BC survivors. However, larger-scale clinical trials with robust methodological designs are required to validate and extend our findings.
{"title":"Chinese Medicines Treatment for Sleep Disturbance in Breast Cancer Survivors: A Network Meta-Analysis.","authors":"Chia-Wen Chuang, Ming-Yen Tsai, Shih-Chung Wu, Wen-Chun Liao","doi":"10.1177/15347354241308857","DOIUrl":"10.1177/15347354241308857","url":null,"abstract":"<p><strong>Background: </strong>Sleep disturbance and insomnia are common adverse events in patients with breast cancer (BC). Traditional Chinese Medicine (TCM) treatment for sleep disturbance includes acupuncture, acupressure, auricular acupressure/auricular acupuncture, and Qigong. However, the specific efficacy of these TCM treatment remains unclear.</p><p><strong>Materials and methods: </strong>This systematic review and network meta-analysis (NMA) investigated the effects of various TCM treatment on improving sleep quality in BC survivors.</p><p><strong>Methods: </strong>Only randomized controlled trials (RCTs) reporting the results of TCM treatments were included. The main NMA included 12 RCTs involving 1011 participants. The risk of bias was assessed using the RoB 2 tool for randomized controlled trials. The certainty of evidence of the NMA was assessed in accordance with GRADE (the Grading of Recommendations, Assessment, Development, and Evaluations).</p><p><strong>Results: </strong>Acupressure, acupuncture, auricular acupuncture/auricular acupressure, and qigong were identified as optimal TCM treatment (P < .05) for enhancing sleep quality in BC survivors.</p><p><strong>Conclusion: </strong>Our results provide some evidence that TCM treatment, particularly acupressure, can be beneficial in improving sleep quality in BC survivors. However, larger-scale clinical trials with robust methodological designs are required to validate and extend our findings.</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354241308857"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11662389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863248","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}
Background: A statistical model is essential in determining the appropriate predictive indicators for therapies in many types of cancers. Predictors have been compared favorably to the traditional systems for many cancers. Thus, this study has been proposed as a new standard approach. A recent study on the clinical efficacy of Atractylodes lancea (Thunb) DC. (AL) revealed the higher clinical benefits in patients with advanced-stage intrahepatic cholangiocarcinoma (ICC) treated with AL compared with standard supportive care. We investigated the relationships between clinical efficacy and pharmacokinetic parameters of serum bioactivity of AL and its active constituent atractylodin and determined therapeutic ranges.
Methods: Group 1 of advanced-stage ICC patients received daily doses of 1000 mg of standardized extract of the capsule formulation of AL (CMC-AL) for 90 days. Group 2 received daily doses of 1000 mg of CMC-AL for 14 days, followed by 1500 mg for 14 days, and 2000 mg for 62 days. Group 3 (control group) received palliative care. Cox proportional hazard model and Receiver Operating Characteristic (ROC) were applied to determine the cut-off values of AUC0-inf, Cmax, and Cavg associated with therapeutic outcomes. Number needed to treat (NNT) and relative risk (RR) were also applied to determine potential predictors.
Results: The AUC0-inf of total AL bioactivity of >96.71 µg hour/ml was identified as a promising predictor of disease prognosis, that is, progression-free survival (PFS) and disease control rate (DCR). Cmax of total AL bioactivity of >21.42 was identified as a predictor of the prognosis of survival. The therapeutic range of total AL bioactivity for PFS and DCR is 14.48 to 65.8 µg/ml, and for overall survival is 10.97 to 65.8 µg/ml. Conclusions: The predictors of ICC disease prognosis were established based on the pharmacokinetics of total AL bioactivity. The information could be exploited to improve the clinical efficacy of AL in patients with advanced-stage ICC. These predictors will be validated in a phase 2B clinical study.
{"title":"Pharmacokinetic Analysis of Prognostic Factors in Patients With Advanced-Stage Intrahepatic Cholangiocarcinoma Following the Administration of Capsule Formulation of the Standardized Extract of <i>Atractylodes lancea</i> (Thunb) DC.","authors":"Teerachat Saeheng, Juntra Karbwang, Anurak Cheomung, Nisit Tongsiri, Tullayakorn Plengsuriyakarn, Kesara Na-Bangchang","doi":"10.1177/15347354231223967","DOIUrl":"10.1177/15347354231223967","url":null,"abstract":"<p><strong>Background: </strong>A statistical model is essential in determining the appropriate predictive indicators for therapies in many types of cancers. Predictors have been compared favorably to the traditional systems for many cancers. Thus, this study has been proposed as a new standard approach. A recent study on the clinical efficacy of <i>Atractylodes lancea</i> (Thunb) DC. (AL) revealed the higher clinical benefits in patients with advanced-stage intrahepatic cholangiocarcinoma (ICC) treated with AL compared with standard supportive care. We investigated the relationships between clinical efficacy and pharmacokinetic parameters of serum bioactivity of AL and its active constituent atractylodin and determined therapeutic ranges.</p><p><strong>Methods: </strong>Group 1 of advanced-stage ICC patients received daily doses of 1000 mg of standardized extract of the capsule formulation of AL (CMC-AL) for 90 days. Group 2 received daily doses of 1000 mg of CMC-AL for 14 days, followed by 1500 mg for 14 days, and 2000 mg for 62 days. Group 3 (control group) received palliative care. Cox proportional hazard model and Receiver Operating Characteristic (ROC) were applied to determine the cut-off values of AUC<sub>0-inf</sub>, <i>C</i><sub>max</sub>, and <i>C</i><sub>avg</sub> associated with therapeutic outcomes. Number needed to treat (NNT) and relative risk (RR) were also applied to determine potential predictors.</p><p><strong>Results: </strong>The AUC<sub>0-inf</sub> of total AL bioactivity of >96.71 µg hour/ml was identified as a promising predictor of disease prognosis, that is, progression-free survival (PFS) and disease control rate (DCR). <i>C</i><sub>max</sub> of total AL bioactivity of >21.42 was identified as a predictor of the prognosis of survival. The therapeutic range of total AL bioactivity for PFS and DCR is 14.48 to 65.8 µg/ml, and for overall survival is 10.97 to 65.8 µg/ml. <b>Conclusions:</b> The predictors of ICC disease prognosis were established based on the pharmacokinetics of total AL bioactivity. The information could be exploited to improve the clinical efficacy of AL in patients with advanced-stage ICC. These predictors will be validated in a phase 2B clinical study.</p><p><strong>Trial registration: </strong>TCTR20210129007 (TCTR: www.clinicaltrials.in.th).</p>","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"23 ","pages":"15347354231223967"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10832411/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139642081","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}