Efficacy and Safety of Qibei Jiedu Formula for Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLI FENG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Basic Treatment Combined with Qibei Jiedu Formula
DrugParticipants 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).
Standard Basic Treatment Combined with Qibei Jiedu Formula simulator
DrugParticipants 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
Blood Inflammatory Levels
A 5-mL sample of venous blood was collected from the median cubital vein of each patient, stored in a serum separator tube, and analyzed for inflammatory marker levels using enzyme-linked immunosorbent assay (ELISA).
Time frame
At baseline and at the end of treatment (Day 21).2
Skin Microbiota Analysis
Samples were collected by swabbing a 5 cm × 5 cm area along the central axis of the radiation field and its border, using non-irradiated skin 2 cm outside the field edge as a control. A sterile cotton swab was used to swab the target area, which was divided into four rectangular sub-areas from top to bottom. The swab tip was kept in firm contact with the skin and moved back and forth at least five times in each sub-area. After swabbing each sub-area, the swab was rotated 90° before proceeding to the next to ensure maximal microbial collection over the entire swab head. After collection, the swab was immediately placed in preservation solution. Skin microbiota analysis was performed using 16S rRNA gene sequencing.
Time frame
At baseline and at the end of treatment (Day 21).3
Lymphocyte Subset Analysis
A 5-mL venous blood sample was collected from the median cubital vein of each patient, stored in an EDTA-anticoagulated tube, and analyzed for peripheral blood lymphocyte subset distribution by flow cytometry.
Time frame
At baseline and at the end of treatment (Day 21).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
LI FENG
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: