Clinical trial · Interventional
Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula
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
NCT06560385CI-TRIAL-00080651terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Why stopped (as posted): No enough subjects within the recruitment period
Summary
Brief summary (as posted)
This study aims to explore the efficacy and safety of a synbiotic formula (BLHK03) in alleviating chemotherapy-induced alopecia (CIA) in breast cancer patients and the compositional and functional changes in the gut microbiome of breast cancer patients undergoing chemotherapy and treatment with BLHK03.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hair Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active placebo | Dietary Supplement | — | UNRESOLVED |
| BLHK03 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active arm
- description
- Subjects will receive 1 sachet of BLHK03 daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.
- interventionNames
- Dietary Supplement: BLHK03
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- Subjects will receive 1 sachet of active placebo daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.
- interventionNames
- Dietary Supplement: Active placebo
Primary outcomes (1)
- measure
- The proportion of subjects with a score of ≤ 2 on the Dean scale (corresponding to hair loss ≤ 50%) 2 months after the final dose of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLam S, Zhang J, Yang K, Chu LC, Zhu W, Tang W, Chan FKL, Chan PKS, Wu WKK, Ng SC. Modulation of gut microbiota impacts diet-induced and drug-induced alopecia in mice. Gut. 2022 Nov;71(11):2366-2369. doi: 10.1136/gutjnl-2021-326320. Epub 2022 Jan 5. No abstract available. PMID 34987064
- BACKGROUNDKhazaei Y, Basi A, Fernandez ML, Foudazi H, Bagherzadeh R, Shidfar F. The effects of synbiotics supplementation on reducing chemotherapy-induced side effects in women with breast cancer: a randomized placebo-controlled double-blind clinical trial. BMC Complement Med Ther. 2023 Sep 26;23(1):339. doi: 10.1186/s12906-023-04165-8. PMID 37752516
- BACKGROUNDPatel DP, Swink SM, Castelo-Soccio L. A Review of the Use of Biotin for Hair Loss. Skin Appendage Disord. 2017 Aug;3(3):166-169. doi: 10.1159/000462981. Epub 2017 Apr 27. PMID 28879195