Integrative Cancer Therapies最新文献

Background: Chemotherapy-induced nausea and vomiting is a common problem in patients undergoing chemotherapy, influencing quality of life (QoL) and daily activities. This study will investigate whether therapists' positive communication may strengthen positive treatment expectations and induce antiemetic effects during antiemetic treatment using standard care, sham acupuncture, or verum acupuncture, compared to neutral communication. It will also investigate whether a variety of patient, therapist and treatment components modify the treatment outcomes.

Methods: This is a trial protocol for a randomized, sham-controlled, patient- and evaluator-blinded clinical trial. Patients (n = 198 patients according to a sample size calculation) with breast, colorectal, or bladder cancer undergoing neo-/adjuvant moderately to highly emetogenic chemotherapy are being randomized in 2 × 3 factorial design to the following conditions: 1. neutral or 2. positive communication style regarding expected treatment effects, during the antiemetic treatment types: A) standard care only (including antiemetics, no acupuncture), or, in addition to standard care, B) sham acupuncture with telescopic non-penetrating needles, or C) verum, penetrating acupuncture. The 2 communication styles 1 and 2 are carried out during the antiemetic treatments given by an intervention therapist immediately pre and post (20 minutes × 2) an intravenous chemotherapy session. Data are being collected at baseline on the day before the chemotherapy session, daily for 10 days, at a 10-day follow-up, and at a follow-up after completing the entire chemotherapy period, lasting about 6 months. Primary outcome is mean score Visual Analog Scale nausea grading for the first 5 days of the chemotherapy session period. Secondary outcomes are for example, vomiting, treatment expectations, QoL, daily and physical activity, and physiological measures. Treatment effect modifiers will be analyzed, for example, blinding success, treatment expectations, and previous nausea experiences.

Conclusions: This trial will expand integrative cancer care's understanding of the effects of communication for strengthening treatment expectations and thus alleviating chemotherapy-induced nausea and vomiting. If proven effective, the communication model of strengthening positive treatment expectations in patients with risk for nausea and vomiting can be implemented in routine clinical care as part of side-effect management for patients with cancer.

Trial registration: US National Institutes of Health, https://clinicaltrials.gov/study/NCT03232541?term=NCT03232541&rank=1), # NCT03232541.

This study investigated the effects of peach gum polysaccharide (PGP) on chemotherapy-induced intestinal injury and behavioral changes in mice. Female C57BL/6 mice were injected with E0771 breast cancer cells and divided into 3 groups: control, chemotherapy (pirarubicin), and PGP treatment (pirarubicin plus PGP). Behavioral tests, colon length measurement, tissue staining, 16S rDNA sequencing, and metabolomics were performed. Transcriptomic data of colon and hippocampal tissues were analyzed and validated by Western blotting. PGP significantly alleviated colon damage, reduced inflammation and apoptosis, and restored colon length. It mitigated depressive behaviors by suppressing inflammasome activation in the hippocampus, increased gut microbiota diversity, and improved depression-associated metabolites. After the depletion of the intestinal flora, the antidepressant effect of PGP is significantly weakened. These findings suggest that PGP protects against chemotherapy-induced intestinal and behavioral damage by modulating the gut microbiota and gut-brain axis.

Introduction: Cancer treatment with chemotherapy frequently leads to side effects such as fatigue, pain, nausea, and anxiety. Healing Touch is a non-invasive complementary therapy often used by cancer patients to address side effects of treatment. To better inform the use of complementary therapies, there is a need to understand the biological mechanisms underlying the effects of such treatments.

Methods: This study included 44 patients with cervical cancer undergoing chemoradiation randomized into a Healing Touch (HT), a relaxation training (RT) and a usual care (UC) group. An exploratory metabolomics analysis was conducted on plasma samples taken at baseline, 4, and 6 weeks of ongoing treatment (4 sessions per week).

Results: A multivariate data analysis revealed no significant separation in metabolites between the 3 groups. Univariate data analysis revealed changes in metabolites between baseline and week 6 within each group. The main findings were lower levels of acylcarnitines, bile acids and proline in the HT group, higher levels of fatty acids in the HT and RT groups, and lower levels of kynurenine and quinolate in the UC group. The network of correlations between metabolites shows clear differences in correlations between steroids, fatty acids, sphyngomyelins, amino acids, and γ glutamyl peptides between the 3 groups, suggesting a more flexible and resilient metabolism in the HT and RT groups compared with UC.

Conclusion: This first exploratory study investigating metabolic effects of Healing Touch in cancer patients indicated suggestive differences in metabolic signatures which need further investigation in a larger study.

Background: Radiation therapy is commonly used for the curative or palliative treatment of lung, esophageal, breast, or mediastinal tumors, with radiation-induced esophagitis (RIE) being a prevalent adverse event. Despite its high incidence, no cure has been identified for RIE, and validated treatment methods remain elusive. This systematic review explores global clinical research on herbal medicines for RIE treatment, assessing their efficacy in prevention and treatment.

Methods: A comprehensive literature search across 5 databases targeted randomized controlled clinical trials (RCTs). RCTs published before June 2024 were eligible if they investigated herbal medicine use for RIE prevention or treatment. Using Cochrane methodology and RevMan 5.4 software, a meta-analysis was conducted, and the certainty of evidence was evaluated with the GRADE system.

Results: Following the literature selection process, 81 RCTs with 7283 patients were included in the analysis. All studies administered herbal medicine to the treatment group and usual care with conventional medicine to the control group. Meta-analysis revealed that, in terms of overall incidence rate, herbal medicine demonstrated a significantly greater preventive effect compared to usual care (relative risk [RR]: 0.71; 95% CI: 0.65-0.78). Similarly, herbal medicine showed superior efficacy in improving RIE treatment outcomes compared to usual care (RR: 1.29; 95% CI: 1.21-1.38). Herbal medicine exhibited a comparable safety profile with fewer gastrointestinal adverse events and no significant liver toxicity.

Conclusions: Herbal medicine demonstrated significant benefits in reducing RIE incidence, delaying onset, alleviating symptoms, and shortening duration in patients undergoing radiation therapy for thoracic malignancies. However, due to limited certainty of the evidence, well-designed, large-scale RCTs are essential to establish the clinical effectiveness of herbal medicine for prevention and treatment, ensuring high-quality evidence for incidence rate and treatment effective rates.

Background: Cancer remains one of the leading causes of death worldwide, underscoring the need for novel therapies. SH003, an herbal mixture composed of Astragalus membranaceus, Angelica gigas, and Trichosanthes kirilowii, is a traditional Korean medicine formulation with potential to enhance chemotherapy efficacy and reduce toxicity. This study aimed to assess the safety and determine maximum tolerated dose of SH003 in combination with docetaxel in patients with advanced solid tumors, specifically lung and breast cancer.

Methods: This Phase I, multi-center, open-label, dose-escalation study enrolled patients with advanced lung or breast cancer. Participants received SH003 orally at doses of 2400, 3600, or 4800 mg daily, alongside intravenous docetaxel (75 mg/m²) every 21 days. A 3 + 3 dose-escalation design was employed to determine the maximum tolerated dose. Safety assessments and adverse event monitoring were conducted at each treatment cycle.

Results: Twelve participants were enrolled. SH003 was well tolerated up to 4800 mg/day, with no dose-limiting toxicities attributed to SH003. The most common adverse events were neutropenia, primarily associated with docetaxel, and mild dermatologic reactions such as eczema, rash acneiform, and pruritus. Preliminary evidence of disease stabilization was observed in several participants.

Conclusion: The combination of SH003 and docetaxel demonstrated a favorable safety profile, with 4800 mg/day identified as maximum tolerated dose for SH003. These findings support further investigation in Phase II trials to assess therapeutic efficacy.Trial Registration: Clinical Research Information Service (https://cris.nih.go.kr) KCT0004770.

Background: Evidence regarding Chinese herbal medicine for facial rash related to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) is limited. Therefore, this study aimed to investigate whether ex ternal application of a Xiaozhen zhiyang (XZZY) decoction is effective for EGFR-TKI-related facial rash in Chinese patients.

Methods: In this prospective cohort study, 123 participants with EGFR-TKI-related facial rash were recruited from July 18, 2019 to May 20, 2021. The intervention was external application of the XZZY decoction twice daily for 2 weeks using a facial mask. Treatment efficacy, change in the WoMo score, and quality of life were evaluated as endpoints.

Results: The average age of the 123 enrolled participants was 54.83 ± 12.45 years, and 48.78% were female. The total efficiency of treatment was 93.5%, including 12 (10%) cases were cured, 20 (16.26%) cases were markedly improved and 83 (67.48%) cases were improved. The generalized estimating equations showed decreased WoMo scores, itching, and pain, as well as an improved quality of life after the treatment. Only 1 participant reported skin allergies, and no other adverse effects were reported.

Conclusion: This study showed the effectiveness and safety of a XZZY decoction for EGFR-TKI-related rash.

Objective: To evaluate the clinical efficacy and safety of Shuanghuang Yangxue Decoction in treating lung cancer patients with cancer-related anemia (CRA) accompanied by serum iron deficiency.

Method: One hundred lung cancer patients with CRA and serum iron deficiency were included in this prospective randomized controlled study and randomly divided into control and treatment groups. The treatment group received Shuanghuang Yangxue Decoction plus ferrous succinate, while the control group received ferrous succinate alone. Related indicators were observed and recorded before and after treatment. Statistical analysis was performed using SPSS 26.0.

Results: The effective correction rate of anemia in the treatment group was significantly higher than that in the control group (64 vs 34%, P < .01). Through stratified analysis of patients with moderate anemia, the effective correction rate in the treatment group was significantly higher than that in the control group (75 vs 45%, P < 0.01). After treatment, the treatment group showed statistically significant differences (P < .05) in peripheral blood routine parameters (hemoglobin, erythrocyte count, and hematocrit), anemia indicators (serum iron, ferritin, transferrin saturation, and erythropoietin [EPO]), immune function markers (cytotoxic T lymphocytes [Tc] and natural killer [NK] lymphocytes), and inflammatory factors (interleukin-1β [IL-1β], IL-6, tumor necrosis factor-α [TNF-α], and interferon-γ [IFN-γ]) compared to baseline values. Between-group comparisons showed that mean hemoglobin in the treatment group increased from 106.60 to 119.86 g/L, which was not significantly different from the control group increase from 110.00 to 116.18 g/L (P > .05). However, mean serum iron in the treatment group increased from 7.03 to 12.33 μmol/L, which was significantly higher than the control group increase from 7.33 to 9.45 μmol/L (P < .01). Throughout the study, no adverse reaction events occurred in either group.

Conclusion: Shuanghuang Yangxue Decoction demonstrates superior efficacy compared to ferrous succinate alone in treating lung cancer CRA with serum iron deficiency. It effectively corrects anemia, increases serum iron levels, reduces inflammation, and is both safe and effective.

Background: Chinese herbal medicine (CHM), a commonly used alternative therapy, has been reported to reduce the side effects of cancer treatments and improve the quality of life (QOL) in breast cancer (BC) patients. However, there is limited research on the effects of CHM in BC patients experiencing hot flushes (HFs) during adjuvant chemotherapy. We conducted a non-randomized controlled trial to evaluate the effectiveness of CHM on side effects, QOL, and changes in meridian electrodermal activity.

Methods: Forty-eight patients with stage I-III BC undergoing adjuvant chemotherapy were non-randomly assigned to either a 24-week CHM treatment group or a 24-week non-CHM control group. The CHM intervention involved a combination of Jia Wei Xiao Yao San and Er Zhi Wan in a 3:1 ratio, with a total daily dose of 4 g taken 3 times a day. The primary outcome was the occurrence of 10 or more HFs per week and the severity of symptoms, rated using a visual analog scale (1-10). Secondary outcomes included the Functional Assessment of Cancer Therapy-Breast Cancer questionnaire to assess health-related QOL, and meridian energy analysis to measure skin electrical conductance and sympathetic activity. The difference between the CHM and non-CHM groups in individual changes from baseline to week 24 was evaluated using an independent t-test.

Results: A total of 43 participants completed the study, with 25 in the CHM group and 18 in the control group. The CHM group showed a statistically significant reduction in HF frequency at 12 and 24 weeks and a decrease in HF severity at 12 weeks compared to the control group (P < .05). Physical well-being and specific concerns scores also improved significantly over time in the CHM group compared to the control group (P < .05). While CHM treatment did not lead to significant changes in overall electrical conductance at acupoints (P = .251), it did significantly affect specific meridians, including the heart, liver, and kidney (P = .032, P = .035, and P = .035, respectively). Additionally, sympathetic activity was reduced in the CHM group after completing chemotherapy (P = .045).

Conclusions: CHM therapy appears to have a preventive effect on chemotherapy-related HFs in BC patients and is safe, with no severe adverse effects observed.