Evaluating probiotics for breast cancer chemotherapy side effects
To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer
This study is testing if taking a special type of probiotics can help breast cancer patients feel better during chemotherapy by reducing side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | GenMont Biotech Incorporation Industry-sponsored |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06039644 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of probiotics, specifically a lactobacillus composite strain, in alleviating chemotherapy-associated side effects in breast cancer patients. Participants will consume probiotic sachets for six months while undergoing chemotherapy, with the aim of improving their quality of life and treatment adherence. The study targets patients receiving anthracycline and taxane-based chemotherapy, which are commonly used in breast cancer treatment. By focusing on the gut microbiota's role, the research seeks to provide a novel approach to managing chemotherapy side effects.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 80 with stage I-III breast cancer undergoing anthracycline or taxane-based chemotherapy.
Not a fit: Patients who are pregnant, have certain gastrointestinal conditions, or are outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for breast cancer patients undergoing chemotherapy by reducing side effects.
How similar studies have performed: While the use of probiotics in cancer care is gaining interest, this specific approach to managing chemotherapy side effects in breast cancer patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stage I-III breast patients using anthracycline-based and taxane-based chemotherapy (not limited before or after chemotherapy/surgery) * BMI \> 18 kg/m\^2 * Age between 20 and 80 years old * Patients judged by physicians to participate in this trial and who are willing Exclusion Criteria: * Pregnant or lactating female patients * Patients with bariatric surgery, gastrointestinal resections, Crohn's disease, celiac disease * BMI \< 18 kg/m\^2 * Patient who have severe allergy to soybeans or peanuts * Those who are under 20 years old or over 80 years old
Where this trial is running
Taipei
- Mackay Memorial Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Po-Sheng Yang, MD, PhD — Mackay Memorial Hospital
- Study coordinator: Fang-Kuei Lin, Master
- Email: meitung@genmont.com.tw
- Phone: +886-6-505-2151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.