Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula
NCT ID: NCT06560385
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-09-11
2026-08-18
Brief Summary
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Detailed Description
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Currently, there is no documentation of potential probiotic-drug interactions in breast cancer patients undergoing chemotherapy. A previous randomized controlled trial reported no adverse event associated with the use of synbiotics in breast cancer patients during the treatment period(9). Beneficial effects on chemotherapy-induced fatigue and abnormal stool consistency were also observed in subjects receiving synbiotics(9).
Biotin is a water-soluble vitamin that is naturally present in some food and available as a dietary supplement for healthy hair and nails due to its role in keratin production. Most healthy individuals achieve adequate intake of biotin through a well-balanced diet. Current recommendation for biotin by the Food and Nutrition Board (FNB) at the National Academies of Sciences, Engineering, and Medicine stated that the daily adequate intake (AI) for adults is 30 mcg/day. Although biotin has been widely used as dietary supplement, data on the actual benefit of its effect on hair growth is limited(10).
The use of B. longum HK003 in alleviating chemotherapy-induced alopecia in breast cancer patients has not been explored. This pilot, double-blind, randomised, placebo-controlled trial aims to explore on the efficacy and safety of a synbiotic formula (BLHK03) in alleviating chemotherapy-induced alopecia (CIA) in breast cancer patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Active arm
Subjects will receive 1 sachet of BLHK03 daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.
BLHK03
BLHK03 consists of a blend of probiotics (20 billion CFU in 1 sachet) and prebiotic compounds
Placebo arm
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.
Active placebo
Active placebo contains 5mcg of Vitamin B7
Interventions
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BLHK03
BLHK03 consists of a blend of probiotics (20 billion CFU in 1 sachet) and prebiotic compounds
Active placebo
Active placebo contains 5mcg of Vitamin B7
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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GenieBiome Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jessica Ching, PhD
Role: STUDY_DIRECTOR
GenieBiome Limited
Locations
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GenieBiome Limited
Hong Kong, , Hong Kong
Heal Medical
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Lam 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.
Khazaei 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.
Patel 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.
Other Identifiers
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BCIA Study
Identifier Type: -
Identifier Source: org_study_id
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