Clinical Study on Huangqin Decoction in Treating HR-Positive Patients with Abemaciclib-Related Diarrhea - Study Protocol for a Randomized Controlled Trial

Background: Diarrhea is one of the most common adverse drug reactions of Abemaciclib, which severely affects the quality of life of patients. Traditional Chinese medicine has been widely used in the treatment of drug-related diarrhea and has achieved good clinical efficacy. This study aims to evaluate the clinical therapeutic effect of Huangqin Decoction, a classical Chinese medicine formula, on Abemaciclib-related diarrhea. Methods: This study was designed as a randomized double-blind controlled trial, with two parallel groups. A total of 140 patients aged between 18 and 75 years,diagnosed with HR-positive breast cancer and taking Abemaciclib, were randomly divided into the intervention group and the control group. After enrollment, both groups received 2 months of traditional Chinese medicine treatment, with the experimental group receiving Huangqin Decoction and the control group receiving placebo treatment. The primary outcome measure was the incidence of graded diarrhea, while the secondary outcome measures included diarrhea clinical symptom score,frequency and duration of diarrhea,KPS (Karnofsky Performance Status),safety evaluation index,and the observational indicators are ORR (Overall Response Rate) and PFS (Progression-Free Survival). Discussion: This study aims to observe the efficacy of Huangqin Decoction in treating Abemaciclib-related diarrhea, providing new treatment ideas and reliable scientific evidence for Abemaciclib-related diarrhea. The impact of Huangqin Decoction on the tumor status of HR-positive breast cancer patients still needs further follow-up. Trial Registration: Chictr.org.cn Identifier: ChiCTR2400084945. Registered on May 28,2024.