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 aimed to evaluate the efficacy of YH0618 granule in preventing chemotherapy-induced hair loss in breast cancer patients through a randomized, double-blind, multi-center clinical trial. Patients were divided into two groups: one receiving YH0618 granules and the other a placebo, with treatments administered during the first four chemotherapy cycles. The primary outcome measured was the time to reach grade II hair loss, while secondary outcomes included changes in hair quality, facial and thumbnail color, quality of life, fatigue, and various medical indicators. The study sought to provide evidence for the clinical use of YH0618 and its potential mechanism related to kidney deficiency, as per Chinese Medicine theory.