Using a synbiotic formula to reduce hair loss in breast cancer patients undergoing chemotherapy
A Pilot, Double-blind, Randomised, Placebo-controlled Trial on the Efficacy of a Synbiotic Formula (BLHK03) in Alleviating Chemotherapy-induced Alopecia (CIA) in Breast Cancer Patients
This study is testing if a special blend of probiotics and prebiotics can help reduce hair loss in women with breast cancer who are starting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | GenieBiome Limited Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, cyclophosphamide |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT06560385 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of a synbiotic formula, BLHK03, in reducing chemotherapy-induced alopecia in breast cancer patients. The approach is based on previous findings in mice that showed a probiotic could protect against hair loss related to chemotherapy. The study will also examine changes in the gut microbiome of participants receiving this treatment. Eligible participants include newly diagnosed female breast cancer patients who are about to start chemotherapy. The study aims to provide insights into the potential benefits of synbiotics in managing side effects of cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 60 who are newly diagnosed with stage I, II, or III breast cancer and are about to begin chemotherapy.
Not a fit: Patients with pre-existing hair loss conditions or those planning to undergo scalp cooling may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help breast cancer patients maintain their hair during chemotherapy, improving their quality of life.
How similar studies have performed: While previous studies have shown positive effects of synbiotics in breast cancer patients, this specific approach to alleviate chemotherapy-induced hair loss is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females aged between 18 and 60 years who are newly diagnosed with stage I, II or III breast cancer * Planned chemotherapy including an anthracycline or taxane to be completed within 6 months * Mentally capable to participate in the study and provide informed consent Exclusion Criteria: * Pre-existing female-pattern baldness resembling picture I-3 or higher on the Savin scale at baseline * History of hair transplantation, psoriasis or severe scalp infection * Undergoing or plan to receive scalp cooling * Plan for immunotherapy * Known pregnancy or lactating * Severe cardiac, hepatic, renal, pulmonary and haematic lesions or other life-threatening conditions * Use of antibiotics, probiotics or prebiotics one month prior to enrolment * No other alternative or complementary treatment for the cancer condition that may affect the gut microbiome analysis * History of allergy to probiotics or lactose * History of chemotherapy for other conditions
Where this trial is running
Hong Kong and 1 other locations
- GenieBiome Limited — Hong Kong, Hong Kong (Not_yet_recruiting)
- Heal Medical — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Emily Chiu, BSc
- Email: emilychiu@g-niib.com
- Phone: 97405209
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.