Efficacy and Safety of Qibei Jiedu Formula Versus Placebo in Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients: A Prospective, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Grade ≥2 Acute Radiation Dermatitis
研究概览
简要总结
- 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.
- To observe the safety profile of Qibei Jiedu Formula.
- To investigate the potential role of Qibei Jiedu Formula in improving patients' quality of life.
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed unilateral stage I-III non-inflammatory breast cancer, having undergone breast-conserving surgery or modified radical mastectomy, and having received or planned to receive standard adjuvant therapy according to current clinical guidelines.
- •Scheduled to receive postoperative adjuvant radiotherapy using a hypofractionated regimen (40-50 Gy/15 fractions) as recommended by the NCCN Breast Cancer Guidelines and the CSCO Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition).
- •Meeting the TCM diagnostic criteria for the syndrome of Qi-Yin Deficiency with Blood Stasis and Toxin Accumulation.
- •Karnofsky Performance Status (KPS) score ≥
- •Age ≥18 years, female.
- •Voluntarily participating in the study and providing written informed consent.
排除标准
- •Presence of grade 4 radiation dermatitis requiring urgent intervention at enrollment or during the study.
- •Prior radiotherapy to the breast or chest within the past 3 months.
- •Any skin condition that may interfere with the assessment of radiation dermatitis, such as active infection, atopic dermatitis, psoriasis, vitiligo, active collagen vascular disease (e.g., scleroderma, lupus erythematosus), or other known autoimmune disorders significantly altering skin appearance or physiological response.
- •Pre-existing grade ≥2 hepatic/renal dysfunction or hematological toxicity (according to CTCAE v5.0 criteria) before treatment.
- •Concurrent participation in other clinical trials or concurrent use of other Chinese herbal preparations.
- •Unstable mental status or inability to cooperate with the study procedures.
- •Pregnant or lactating patients.
- •Known allergy to any component of the herbal formula used in this study.
研究组 & 干预措施
Treatment Group
Standard basic treatment + Qibei Jiedu Formula
干预措施: Standard Basic Treatment Combined with Qibei Jiedu Formula (Drug)
Control Group
Standard basic treatment + Qibei Jiedu Formula simulator (containing 5% of the original formula dosage)
干预措施: Standard Basic Treatment Combined with Qibei Jiedu Formula simulator (Drug)
结局指标
主要结局
Incidence of Grade ≥2 Acute Radiation Dermatitis
时间窗: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
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.
次要结局
- Time to Onset of Grade 2 Acute Radiation Dermatitis(During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49))
- Time to Wound Healing of Radiation Dermatitis(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(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(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)(Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49))
- Traditional Chinese Medicine (TCM) Syndrome Score(Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49))
- Skin Colorimetric Changes Assessed by Skin Reflectance Spectrophotometry (SRS)(During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49))
研究者
LI FENG
Director and Chief Physician, Department of Traditional Chinese Medicine
Cancer Institute and Hospital, Chinese Academy of Medical Sciences