Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula

NCT06560385 | Recruiting

• 1 other identifier: BCIA Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer; Hair Loss

Keywords

Breast Cancer; Hair Loss; Chemotherapy; Synbiotic

Outcome Measures

Primary Outcomes (1)

• 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

  The change of Dean scale (corresponding to hair loss) after chemotherapy compared to baseline. Score 0 means no hair loss and score 4 means all hair is fallen down.

  Baseline to 2 months after the final dose of chemotherapy

Secondary Outcomes (2)

• Gut microbial change at 2 months after the final dose of chemotherapy

  Baseline to 2 months after the final dose of chemotherapy

• Adverse event rates related to the study during the study period

  Baseline to 2 months after the final dose of chemotherapy

Study Arms (2)

Active arm

ACTIVE COMPARATOR

Subjects will receive 1 sachet of BLHK03 daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.

Dietary Supplement: BLHK03

Placebo arm

PLACEBO COMPARATOR

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.

Dietary Supplement: Active placebo

Interventions

BLHK03 DIETARY_SUPPLEMENT

BLHK03 consists of a blend of probiotics (20 billion CFU in 1 sachet) and prebiotic compounds

Active arm

Active placebo DIETARY_SUPPLEMENT

Active placebo contains 5mcg of Vitamin B7

Placebo arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GenieBiome Limited: lead

Study Sites (2)

GenieBiome Limited

Hong Kong, Hong Kong

NOT YET RECRUITING

Heal Medical

Hong Kong, Hong Kong

RECRUITING

Related Publications (3)

• 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.

  PMID: 34987064 BACKGROUND

• 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.

  PMID: 37752516 BACKGROUND

• 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.

  PMID: 28879195 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Alopecia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Ching, PhD

  GenieBiome Limited

  STUDY DIRECTOR

Central Study Contacts

Emily Chiu, BSc

CONTACT

97405209; emilychiu@g-niib.com

Pui Kuan Cheong, MPH

CONTACT

97405209; jcheong@g-niib.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Attending physicians, investigators performing assessments in clinic visits and study participants will be blinded to the group allocation until study completion.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: September 11, 2024
• Primary Completion: August 18, 2025
• Study Completion (Estimated): August 18, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)