A Pilot, Double-blind, Randomised, Placebo-controlled Trial on the Efficacy of a Synbiotic Formula (BLHK03) in Alleviating Chemotherapy-induced Alopecia in Breast Cancer Patients

What this Trial Is About

This research aims to evaluate the effectiveness and safety of a synbiotic formula called BLHK03 in reducing hair loss caused by chemotherapy in women with breast cancer. The study also examines changes in the gut microbiome composition and function in these patients during chemotherapy and treatment with BLHK03. Previous animal studies showed that a probiotic similar to BLHK03 may protect against chemotherapy-related hair loss, but this has not yet been studied in humans. Participants will be randomly assigned to receive either one sachet of BLHK03 daily or an active placebo containing vitamin B7, starting from the beginning of their chemotherapy cycle until two months after their final chemotherapy dose. The trial is double-blind, meaning neither participants nor researchers know who receives BLHK03 or placebo. The chemotherapy regimens include anthracycline or taxane and are planned to complete within six months. During the study, participants will be monitored from the start of chemotherapy until two months after the last dose. Researchers will assess hair loss using the Dean scale, gut microbial changes, and any adverse events related to the study treatments. The main outcome is the proportion of participants with hair loss less than or equal to 50% after chemotherapy. Safety and gut microbiome effects will also be carefully observed throughout the study period.

Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula