Comparison of the Efficacy Between Autologous Fat Infiltration and Treatment With General Measures in the Management of Radiotherapy-induced Radiodermatitis in Breast Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Number of patients with radiodermatitis
研究概览
简要总结
Radiodermatitis is a major problem in oncologic patients, fat grafts previously used for cosmetic procedures have been shown to have regenerative power due to their stem cell content. Our purpose was to compare the clinical changes in the treatment of radiation dermatitis in breast cancer patients with the application of fat graft versus traditional therapy with general measures.A randomized controlled clinical trial was performed, 22 patients were recruited and randomly assigned to one of two groups: an intervention group that received an autologous fat graft and a control group that received treatment with general measures; a 6-week follow-up was performed to determine the presence and classification of radiodermatitis using the LENT/SOMA scales, as well as biopsies. Women were included, with a diagnosis of breast cancer, Eastern Cooperative Oncology Group 0 or 1, attended in our hospital during September 2023 to October 2024, older than 18 years, undergoing lumpectomy or mastectomy and in radiotherapy as part of the treatment scheme for breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years with a confirmed diagnosis of common bile duct cyst by imaging studies and/or intraoperative findings.
- •Patients who received surgical treatment at the institution during the study period.
- •Clinical records with complete information for analysis.
排除标准
- •Patients who do not consent to their inclusion in the study or who for any physical or mental reason are unable to give their consent (patients with cognitive impairment, etc.).
- •Pediatric patients (<18 years).
- •Incomplete clinical records or with loss of postoperative follow-up.
- •Patients with diagnosis of other biliary pathology without evidence of common bile duct cyst.
结局指标
主要结局
Number of patients with radiodermatitis
时间窗: From the start to six week later
The number of patients with radiodermatitis secondary to radiotherapy will be measured from the day they received the treatment until six weeks later.
次要结局
未报告次要终点
研究者
Clotilde Fuentes-Orozco
Principal investigator
Instituto Mexicano del Seguro Social