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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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).
• Препарат 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).

Первичные конечные точки

• Incidence of Grade ≥2 Acute Radiation Dermatitis [Срок оценки: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)]

Вторичные конечные точки (7)

• Time to Onset of Grade 2 Acute Radiation Dermatitis [Срок оценки: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)]
• Time to Wound Healing of Radiation Dermatitis [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)]
• Traditional Chinese Medicine (TCM) Syndrome Score [Срок оценки: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)]
• Skin Colorimetric Changes Assessed by Skin Reflectance Spectrophotometry (SRS) [Срок оценки: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

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

Публикации

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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. PMID 32872216
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• 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
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Идентификаторы

NCT: NCT07380230 · 25/468-5594

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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