Acute Radiation Dermatitis, Breast Cancer, Traditional Chinese Medicine (TCM)
Conditions
Keywords
Acute radiation dermatitis, Integrated Traditional Chinese and Western Medicine, Breast Cancer, Traditional Chinese Medicine
Brief 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.
Detailed description
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.
Interventions
DRUGStandard Basic Treatment Combined with Qibei Jiedu Formula
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).
DRUGStandard Basic Treatment Combined with Qibei Jiedu Formula simulator
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).
Sponsors
LI FENG
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Standard Basic Treatment: All patients will receive guideline-based hypofractionated radiotherapy (40-50 Gy/15 fractions) and routine skin care (e.g., hydrogel dressings or creams) determined by the treating physician. The specific products and usage must be documented in the CRF and maintained as stable as possible after enrollment. Add-on Intervention: Patients will be randomly assigned to receive either Qibei Jiedu Formula or its simulator (5% of the original formula dosage), taken from the first day of radiotherapy. One decocted dose (divided into two 100-mL bags) is taken twice daily for 21 days (synchronized with radiotherapy).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 ≥70. * Age ≥18 years, female. * Voluntarily participating in the study and providing written informed consent.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade ≥2 Acute Radiation Dermatitis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 to Wound Healing of Radiation Dermatitis | During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49) | 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. |
| 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) | 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 |
| 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 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 |
| 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) | 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 |
| Traditional Chinese Medicine (TCM) Syndrome Score | Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49) | 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 |
| 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) | 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. |
Countries
China
Contacts
CONTACTLi Feng, Doctor
CONTACTYirui Yan
Outcome results
None listed