Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula

Trial Title: Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula

NCT ID: NCT06560385

Condition: Breast Cancer
Hair Loss

Conditions: Official terms:
Breast Neoplasms
Alopecia
Alopecia Areata

Conditions: Keywords:
Breast Cancer
Hair Loss
Chemotherapy
Synbiotic

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: All subjects will be randomized into two group to take BLHK03 or active placebo (Vitamin B7) daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.

Primary purpose: Prevention

Masking: Double (Participant, Investigator)

Masking description: Attending physicians, investigators performing assessments in clinic visits and study participants will be blinded to the group allocation until study completion.

Intervention:

Intervention type: Dietary Supplement
Intervention name: BLHK03
Description: BLHK03 consists of a blend of probiotics (20 billion CFU in 1 sachet) and prebiotic compounds
Arm group label: Active arm

Intervention type: Dietary Supplement
Intervention name: Active placebo
Description: Active placebo contains 5mcg of Vitamin B7
Arm group label: Placebo arm

Summary: 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.

Detailed description: In a mice study, it was shown that oral administration of a probiotic isolated from healthy faeces, B. longum HK003, has protective effects against alopecia related to chemotherapy. Mice were treated with 100 mg/kg cyclophosphamide (CYP) once monthly, for 4 months. The CYP-treated mice were then treated with B. longum HK003 for 14 days. Results showed that B. longum treatment significantly enhanced skin thickness histologically. In the subcutis, the quantity and size of anagen follicles were increased, whilst the quantity of atrophic follicles were decreased. 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.

Criteria for eligibility:
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

Gender: Female

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Locations:

Facility:
Name: GenieBiome Limited

Address:
City: Hong Kong
Country: Hong Kong

Status: Not yet recruiting

Contact:
Last name: Jessica Ching, PhD

Phone: 97405209
Email: jessicaching@g-niib.com

Investigator:
Last name: Henry Chun Kin Sze, MD
Email: Principal Investigator

Facility:
Name: Heal Medical

Address:
City: Hong Kong
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Emily Chiu, Bsc

Phone: 9740 5209
Email: emilychiu@g-niib.com

Contact backup:
Last name: Jessica Ching, PhD

Phone: 9740 5209
Email: jessicaching@g-niib.com

Start date: September 11, 2024

Completion date: August 18, 2026

Lead sponsor:
Agency: GenieBiome Limited
Agency class: Industry

Source: GenieBiome Limited

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06560385