Skin Repairing Cream for the Prevention of Radiation Dermatitis and Regulation of Skin Microbial Environment in Breast Cancer: A Multicenter, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Incidence of acute radiation dermatitis (ARD) of grade 2-5
研究概览
简要总结
Acute radiation dermatitis (ARD) is the most common treatment-related adverse reaction following radiotherapy after modified radical mastectomy and/or prosthetic breast reconstruction in breast cancer patients. Moderate-to-severe ARD may compromise cosmetic outcomes and quality of life, and even impair radiotherapy efficacy. Current pharmacological prophylactic measures clinically employed - including topical corticosteroids, superoxide dismutase, and trolamine cream - demonstrate suboptimal efficacy and lack high-level evidence-based medical support. Emerging research indicates an association between cutaneous microbial homeostasis and ARD development, suggesting that maintaining skin surface acidity and modulating microecological balance may represent more effective preventive strategies.
This study evaluates the efficacy and safety of a natural weak-acid macromolecular/small molecular repair cream in preventing ARD among post-operative breast cancer patients receiving radiotherapy through skin microbiome modulation. We enrolled 326 high-risk early-stage breast cancer patients scheduled for post-operative radiotherapy and randomized them to compare the superiority of the natural weak-acid repair cream versus conventional care with moisturizer. Concurrent skin microbiome sampling was performed to assess microecological changes and their impact on ARD development. The findings will provide high-level clinical evidence and theoretical basis for the safer and more effective application of this natural weak-acid repair cream in preventing post-radiotherapy ARD in breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and <70 years, with pathologically confirmed breast cancer;
- •TNM stage T1-3N1-3M0 or T3-4N0M0;
- •Underwent mastectomy with or without implant reconstruction; ④ Medically fit for adjuvant radiotherapy (i.e., in good general condition to tolerate expected side effects such as fatigue, nausea, or vomiting); ⑤ No concurrent use of other skincare products throughout the study period;
- •Voluntary participation with signed informed consent, agreeing to comply with investigator-directed use of the trial product.
排除标准
- •Prior history of radiotherapy;
- •Severe systemic diseases (e.g., significant cardiac, hepatic, or renal dysfunction; immunocompromising conditions such as lymphoma, acquired immunodeficiency syndrome [AIDS], or Wiskott-Aldrich syndrome) or history of other malignancies; ③ Skin reactions due to systemic therapies (e.g., chemotherapy, immunotherapy) or active dermatologic conditions in the treatment area;
- •Known hypersensitivity to the natural weak-acid macromolecular/small molecular repair cream or any of its components; ⑤ Current participation in other clinical trials or participation within the past 3 months, or judged by investigators to have poor compliance that would prevent completion of the study.
研究组 & 干预措施
Experimental group
干预措施: Skin Repairing Cream (Drug)
Control group
干预措施: Cetaphil® Moisturizing Cream as Inactive Control (Other)
结局指标
主要结局
Incidence of acute radiation dermatitis (ARD) of grade 2-5
时间窗: Before RT and within two weeks of completion of RT
次要结局
- quality of life (QoL)(Before RT and within two weeks of completion of RT)