Journal of Clinical Oncology & Advanced Therapy

Abstract

Purpose: This study aimed to evaluate the efficacy of Fangzhi Decoction in preventing gastrointestinal toxicity associated with concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer.

Methods: In this randomized, open-label trial (FZ 2024-04-036) conducted from May 2024 to October 2025, all patients received CCRT. The experimental group was administered Fangzhi Decoction during CCRT, while the control group received Kangfuxin. The Common Terminology Criteria for Adverse Events (version 5.0) were utilized to assess chemoradiotherapy−induced side effects. The primary endpoint during the acute phase was the incidence of nausea, vomiting and diarrhea occurring during CCRT. Secondary endpoints included changes in Karnofsky Performance Status (KPS), and immediate clinical response.

Results: One hundred patients were randomly assigned to either the experimental group (n = 51) or the control group (n = 49). The incidence of G3-4 gastrointestinal toxicity and diarrhea was significantly lower in the experimental group compared to the control group (4.0% vs 20.4%, 2.0% vs 14.2%, respectively; P < 0.05). Following treatment, KPS was significantly higher in the Fangzhi Decoction group than the Kangfuxin group (25.5% vs 14.3%, P < 0.05). The complete response (CR) rate in the Fangzhi Decoction group was significantly greater than that in the Kangfuxin group (83.0% vs 66.0%, P = 0.043).

Conclusions: The findings of this study indicate that the traditional Chinese medicine formulation Fangzhi Decoction can mitigate severe gastrointestinal side effects associated with concurrent chemoradiotherapy for locally advanced cervical cancer, improve patients' physical condition, enhance treatment compliance, and yield immediate therapeutic benefits, thereby warranting its clinical application.