Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Subjective, Objective, Management, and Analytic (SOMA) Score
研究概览
简要总结
This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.
详细描述
Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation.
Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental & Vitamin E has been used with success in Europe and at the University of Iowa.
The focus of this study is to prevent fibrosis through intervention with Trental & Vitamin E. The study has two arms, a control arm and an intervention arm. The study is not blinded. Measurements are taken at standard follow-up visits to measure breast density and lymphedema.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
- •No evidence of metastatic disease.
- •Minimum life expectancy of at least 12 months.
- •Aged greater than 20 years.
- •If female, pregnancy excluded.
- •No documented history of collagen vascular disease.
排除标准
- •Cognitively impaired patients
- •Prisoners
- •No histology available
- •Documented metastatic disease
- •Allergy to Trental
- •Life expectance of less than 12 months.
- •Aged less than 20 years
- •Collagen vascular disease present
- •History of liver disease
- •Use of anticoagulants
研究组 & 干预措施
2
Combined treatment with Pentoxifylline and Vitamin E.
干预措施: Pentoxifylline (Drug)
2
Combined treatment with Pentoxifylline and Vitamin E.
干预措施: Vitamin E (Drug)
结局指标
主要结局
Subjective, Objective, Management, and Analytic (SOMA) Score
时间窗: 18 month post-treatment
A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.
次要结局
- Tissue Compliance(18 months post-treatment)