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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Hong Kong Special Administrative Region
GenieBiome Limited
NOT_YET_RECRUITING
Hong Kong
Heal Medical
RECRUITING
Hong Kong
Contact Information
Primary
Emily Chiu, BSc
emilychiu@g-niib.com
97405209
Backup
Pui Kuan Cheong, MPH
jcheong@g-niib.com
97405209
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2026-08-18
Participants
Target number of participants: 40
Treatments
Active_comparator: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: GenieBiome Limited