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.
Acute Radiation Dermatitis (ARD) following breast cancer radiotherapy has an incidence rate as high as 95%, with grade 3 or higher dermatitis leading to unplanned radiotherapy interruption in 15-20% of patients. This not only compromises treatment efficacy but also significantly impairs patients' quality of life. Current conventional Western medical management primarily relies on corticosteroids and moisturizers, yet faces limitations in efficacy and notable side effects. Developed based on the Fuzheng Quyu Jiedu (Strengthening Vital Qi, Removing Stasis, and Detoxifying) theory, the Qibei Jiedu Formula has shown promising anti-inflammatory, antipruritic, and wound-healing effects in preliminary clinical observations. Led by Professor Feng Li's team from the Cancer Hospital of the Chinese Academy of Medical Sciences, this project adopts a multicenter, randomized, double-blind, placebo-controlled clinical trial design. It plans to enroll 60 breast cancer patients scheduled for radiotherapy to systematically evaluate the clinical efficacy and safety of Qibei Jiedu Formula in preventing and treating ARD. The study aims to provide high-level evidence-based medical data for the integrated Chinese and Western medicine prevention and management of ARD. Furthermore, it seeks to establish a safer and more effective treatment regimen, thereby reducing unplanned radiotherapy interruptions and improving oncologic outcomes. The findings are expected to offer an evidence-based rationale for the TCM-based prevention and treatment of radiation dermatitis, provide a new option for clinical practice, and contribute positively to enhancing the quality of life of cancer patients, holding significant social value.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Participants will commence administration of either the Qibei Jiedu Formula on the first day of radiotherapy. The daily regimen consists of one decocted dose, divided into two sealed bags (specification: 100 mL per bag). One bag is to be taken orally twice daily (morning and evening) for a continuous period of 3 weeks (21 days, synchronized with the radiotherapy course).
Participants will begin taking either the simulator (containing 5% of the original formula dosage) on the first day of radiotherapy. The daily dose consists of one formula unit, decocted and divided into two bags of medicinal liquid (specification: 100 mL per bag). Participants are to take one bag per dose, twice daily (morning and evening), for a continuous period of 3 weeks (21 days, synchronized with the radiotherapy course).
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Incidence of Grade ≥2 Acute Radiation Dermatitis
The proportion of participants who develop Grade 2 or higher acute radiation dermatitis during radiotherapy and within 1 month after completion of radiotherapy, as assessed and confirmed by investigators according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Time to Onset of Grade 2 Acute Radiation Dermatitis
Time from the start of radiotherapy to the first occurrence of Grade 2 acute radiation dermatitis, as confirmed by investigators according to CTCAE v5.0.
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Time to Wound Healing of Radiation Dermatitis
Time from the first documented occurrence of Grade 2 or 3 acute radiation dermatitis to recovery to less than Grade 2 (Grade 0 or 1), as assessed according to CTCAE v5.0 and the Guidelines for Clinical Research of New Chinese Medicines.
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Severity of Radiation Dermatitis Symptoms Assessed by RISRAS
Severity of radiation-induced skin reactions assessed using the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). RISRAS is a composite scale consisting of:a patient-reported symptom score (pain, itching, burning, and impact on daily activities), and a clinician-rated skin reaction score. Scale Range and Interpretation： Total score range: 0 to 36 Higher scores indicate more severe radiation-induced skin reactions
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Quality of Life Assessed by EORTC QLQ-BR23
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23). Scale Range and Interpretation Scores are linearly transformed to a scale of 0 to 100 Higher scores indicate better quality of life or higher symptom burden, depending on the specific subscale, according to the EORTC scoring manual
Time frame: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
Dermatology-related quality of life assessed using the Dermatology Life Quality Index (DLQI). Scale Range and Interpretation Total score range: 0 to 30 Higher scores indicate greater impairment of dermatology-related quality of life
Time frame: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Traditional Chinese Medicine (TCM) Syndrome Score
Severity of Traditional Chinese Medicine (TCM) syndrome assessed using a composite TCM syndrome score scale developed according to the Guidelines for Clinical Research of New Chinese Medicines (2002 edition), the Guidelines for Diagnosis and Treatment of Malignant Tumors in Traditional Chinese Medicine, and External Treatment of Traditional Chinese Medicine. The scale evaluates TCM-related symptoms including fatigue, chest tightness and shortness of breath, heat sensations in the palms and soles, dry mouth and throat, localized pain, skin changes, fever with sweating, irritability and insomnia, lip and nail color changes, subcutaneous ecchymosis, dark urine, and constipation. Treatment efficacy is evaluated based on changes in the total TCM syndrome score from baseline at different assessment time points. Scale Range and Interpretation Total score range: 0 to 54 Higher scores indicate more severe TCM syndrome symptoms
Time frame: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Skin Colorimetric Changes Assessed by Skin Reflectance Spectrophotometry (SRS)
Skin color changes of radiation dermatitis assessed using skin reflectance spectrophotometry with a validated colorimeter. Measurements are performed on the irradiated breast skin, with three readings averaged per site. Skin color is quantified using the CIE L\*a\*b\* color space, and changes from baseline (ΔL\*, Δa\*, Δb\*) are analyzed. Lower ΔL\* values indicate increased pigmentation, and higher Δa\* values indicate increased erythema severity. Δb\* is analyzed as a secondary parameter. Measurements of the contralateral breast are performed at baseline and at the end of radiotherapy to control for systemic skin color changes.
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
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