The Effect and Mechanism of YH0618 Granule on Chemotherapy-Induced Hair Loss in Patients with Breast Cancer: Study Protocol for a Randomized, Double-Blind, Multi-Center Clinical Trial

The study was a randomized, double-blind, multi-center clinical trial involving 214 breast cancer patients, aimed at evaluating the efficacy of YH0618 granule in preventing chemotherapy-induced hair loss. Participants were divided into two groups, receiving either YH0618 granules or a placebo alongside their chemotherapy. The primary outcome measured was the timing of hair loss reaching grade II according to the WHO Toxicity Grading Scale. The study also assessed hair quality, follicle growth, quality of life, fatigue, and various health indicators. YH0618, containing components like black soybean and liquorice, was hypothesized to mitigate hair loss by addressing kidney deficiency, a concept from traditional Chinese medicine. The trial was conducted with ethical oversight and aimed to provide evidence for YH0618's effectiveness and its potential mechanism related to kidney function.