NCT00188552终止2 期
A Phase II Study of the Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To examine the effect of the combination of Pentoxifylline (Trental™) and α-Tocopherol (Vitamin E) on symptomatic radiation induced fibrosis.
研究概览
简要总结
Patients with radiation induced injuries experience significant pain and negative effects on quality of life. Currently, no standard therapy for these patients exists, with some patients treated symptomatically, and others treated with hyperbaric oxygen or pentoxifylline/Vitamin E. This study will examine prospectively the safety and efficacy of using a regimen of pentoxifylline and vitamin E in patients with late radiation induced injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically documented symptomatic radiation induced injury (e.g. fibrosis, necrosis, ulceration)
- •Prior treatment with radiation therapy to the affected area - completed at least 3 months prior to study entry
- •Pain in irradiated volume after 3 months (not attributable to acute inflammation)
- •ECOG performance status must be 0, 1 or 2
- •Life expectancy is greater than 6 months
- •Age 18 to 75 years; informed consent
排除标准
- •Patient is still responding to other therapies for soft tissue injury
- •Active malignant disease
- •Any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment, including but not limited to, acute myocardial infarction, severe coronary artery disease, active internal bleeding or a history of hemorrhagic diathesis, peptic ulcer, impaired kidney or liver function
- •Pregnant or lactating women
- •No contraindication to treatment with pentoxifylline. (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine, recent cerebral and/or retinal hemorrhage)
- •Concurrent treatment with warfarin or other anticoagulant, or with erythromycin
- •Concurrent treatment with other experimental agents or other treatment for fibrosis
- •Patients treated with radiotherapy for breast cancer 3 months to 3 years prior to study entry
- •Blood pressure < 90/60 mm Hg or orthostatic hypotension
结局指标
主要结局
To examine the effect of the combination of Pentoxifylline (Trental™) and α-Tocopherol (Vitamin E) on symptomatic radiation induced fibrosis.
次要结局
- To examine the effect of the combination of Pentoxifylline (Trental™) and α-Tocopherol (Vitamin E) on quality of life in patients with radiation induced fibrosis
- To examine the effect of the combination of Pentoxifylline (Trental™) and α-Tocopherol (Vitamin E) on other patient outcomes, including:
- ECOG Performance status
- To identify factors which modify patients' response to protocol therapy (e.g. radiotherapy treatment factors, prior surgeries, chemotherapy, patient characteristics, etc.)
研究者
研究点 (2)
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