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

Official title

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

Overview

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

• 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).
• 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).

Primary outcome measures

• 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)]

Secondary outcome measures (7)

• 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 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)]
• 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)]
• 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 by Dermatology Life Quality Index (DLQI) [Time frame: 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)]
• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 1 center

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Uni — Beijing

Publications

• Schmeel LC, Koch D, Schmeel FC, Bucheler B, Leitzen C, Mahlmann B, Kunze D, Heimann M, Bruser D, Abramian AV, Schoroth F, Mudder T, Rohner F, Garbe S, Baumert BG, Schild HH, Wilhelm-Buchstab TM. Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment. Polymers (Basel). 2019 Dec 16; PMID 31888185
• 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. PMID 32872216
• 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. PMID 40108640
• Tang Y, Zhou Y, Li HJ. Advances in mesenchymal stem cell exosomes: a review. Stem Cell Res Ther. 2021 Jan 19;12(1):71. doi: 10.1186/s13287-021-02138-7. PMID 33468232
• Wickenheisser VA, Zywot EM, Rabjohns EM, Lee HH, Lawrence DS, Tarrant TK. Laser Light Therapy in Inflammatory, Musculoskeletal, and Autoimmune Disease. Curr Allergy Asthma Rep. 2019 Jul 2;19(8):37. doi: 10.1007/s11882-019-0869-z. PMID 31267251
• Hong JP, Lee SW, Song SY, Ahn SD, Shin SS, Choi EK, Kim JH. Recombinant human epidermal growth factor treatment of radiation-induced severe oral mucositis in patients with head and neck malignancies. Eur J Cancer Care (Engl). 2009 Nov;18(6):636-41. doi: 10.1111/j.1365-2354.2008.00971.x. Epub 2009 Apr 23. PMID 19456848
• Liu C, Wei J, Wang X, Zhao Q, Lv J, Tan Z, Xin Y, Jiang X. Radiation-induced skin reactions: oxidative damage mechanism and antioxidant protection. Front Cell Dev Biol. 2024 Oct 9;12:1480571. doi: 10.3389/fcell.2024.1480571. eCollection 2024. PMID 39450273
• Rube CE, Freyter BM, Tewary G, Roemer K, Hecht M, Rube C. Radiation Dermatitis: Radiation-Induced Effects on the Structural and Immunological Barrier Function of the Epidermis. Int J Mol Sci. 2024 Mar 15;25(6):3320. doi: 10.3390/ijms25063320. PMID 38542294

Identifiers

NCT: NCT07380230 · 25/468-5594

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗