Clinical Trial

Efficacy and Safety of Qibei Jiedu Formula for Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
1. To evaluate the preventive and therapeutic effects of Qibei Jiedu Formula on acute radiation dermatitis in breast cancer patients, including the incidence of grade 2 or higher radiation dermatitis, wound healing time, and symptom relief. 2. To observe the safety profile of Qibei Jiedu Formula. 3. To investigate the potential role of Qibei Jiedu Formula in improving patients' quality of life. 4. To explore the potential mechanism of action of Qibei Jiedu Formula in preventing and treating acute radiation dermatitis in breast cancer patients through exploratory indicators such as inflammatory cytokines and skin microbiota. 5. This study is a small-scale exploratory clinical trial. It aims to collect preliminary efficacy and safety data from 60 participants to assess the "add-on effect" of Qibei Jiedu Formula on top of "standard basic care". The results are intended for estimating effect sizes and generating hypotheses to inform future large-scale studies, not for drawing definitive conclusions.
Trial Details
NCT Number NCT07380230
Lead Sponsor LI FENG
Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Acute Radiation Dermatitis, Traditional Chinese Medicine (TCM), Breast Cancer
Enrollment 60 participants
Start Date 2026-01-27
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-02