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

January 27, 2026 updated by: LI FENG

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

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Standard basic treatment + Qibei Jiedu Formula
Drug: Standard 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).
Experimental: Control Group
Standard basic treatment + Qibei Jiedu Formula simulator (containing 5% of the original formula dosage)
Drug: Standard 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade ≥2 Acute Radiation Dermatitis
Time Frame: 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.
During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Onset of Grade 2 Acute Radiation Dermatitis
Time Frame: 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.
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 Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Traditional Chinese Medicine (TCM) Syndrome Score
Time Frame: 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
Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Skin Colorimetric Changes Assessed by Skin Reflectance Spectrophotometry (SRS)
Time Frame: 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.
During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Inflammatory Levels
Time Frame: At baseline and at the end of treatment (Day 21).
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).
At baseline and at the end of treatment (Day 21).
Skin Microbiota Analysis
Time Frame: At baseline and at the end of treatment (Day 21).
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.
At baseline and at the end of treatment (Day 21).
Lymphocyte Subset Analysis
Time Frame: At baseline and at the end of treatment (Day 21).
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.
At baseline and at the end of treatment (Day 21).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LI FENG

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 27, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/468-5594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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