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

NCT07380230 | Not Yet Recruiting

• 1 other identifier: 25/468-5594
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To observe the safety profile of Qibei Jiedu Formula.
3. 3.To investigate the potential role of Qibei Jiedu Formula in improving patients' quality of life.
4. 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. 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.

Conditions

Acute Radiation Dermatitis; Traditional Chinese Medicine (TCM); Breast Cancer

Keywords

Acute radiation dermatitis; Integrated Traditional Chinese and Western Medicine; Breast Cancer; Traditional Chinese Medicine

Outcome Measures

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.

  During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)

Secondary Outcomes (7)

• 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)

Other Outcomes (3)

• Blood Inflammatory Levels

  At baseline and at the end of treatment (Day 21).

• Skin Microbiota Analysis

  At baseline and at the end of treatment (Day 21).

• Lymphocyte Subset Analysis

  At baseline and at the end of treatment (Day 21).

Study Arms (2)

Treatment Group

EXPERIMENTAL

Standard basic treatment + Qibei Jiedu Formula

Drug: Standard Basic Treatment Combined with Qibei Jiedu Formula

Control Group

EXPERIMENTAL

Standard basic treatment + Qibei Jiedu Formula simulator (containing 5% of the original formula dosage)

Drug: Standard Basic Treatment Combined with Qibei Jiedu Formula simulator

Interventions

Standard Basic Treatment Combined with Qibei Jiedu Formula DRUG

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).

Treatment Group

Standard Basic Treatment Combined with Qibei Jiedu Formula simulator DRUG

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).

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LI FENG: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (11)

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• Bohner AMC, Koch D, Schmeel FC, Rohner F, Schoroth F, Sarria GR, Abramian AV, Baumert BG, Giordano FA, Schmeel LC. Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric L*a*b Color-Space. Cancers (Basel). 2020 Aug 28;12(9):2444. doi: 10.3390/cancers12092444.

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• Dejonckheere CS, Layer JP, Sarria GR, Wiegreffe S, Glasmacher AR, Nour Y, Scafa D, Mudder T, Anzbock T, Giordano FA, Stope MB, Schmeel LC, Gkika E. Non-invasive physical plasma for preventing radiation dermatitis in breast cancer: study protocol for a phase 3 randomised double-blind placebo-controlled trial (NIPP-RD III). Trials. 2025 Mar 19;26(1):97. doi: 10.1186/s13063-025-08806-w.

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• Xie Y, Wang Q, Hu T, Chen R, Wang J, Chang H, Cheng J. Risk Factors Related to Acute Radiation Dermatitis in Breast Cancer Patients After Radiotherapy: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Nov 29;11:738851. doi: 10.3389/fonc.2021.738851. eCollection 2021.

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Li Feng, Doctor

CONTACT

+86-87788030; fengli663@126.com

Yirui Yan

CONTACT

+86-87788030; yyj010906@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director and Chief Physician, Department of Traditional Chinese Medicine

Model Details: 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).

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 2, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)