A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
研究概览
简要总结
The purpose of this study is determine the effects (good and bad) amifostine has on radiation-induced side effects of lymphoma treatment.
详细描述
Patients will be randomized into one of two study groups. One study group will receive amifostine prior to daily radiation therapy and the other group will receive radiation therapy alone.
Amifostine will be administered 30-60 minutes prior to radiation treatment. Vital signs will be monitored 5 minutes and 15 minutes after amifostine injection as well as immediately following radiation treatment.
Patients will also complete a quality-of-life questionnaire on the first and last day of radiation treatment. Follow-up questionnaires will be done at follow-up visits 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after completion of radiation therapy.
Patients will be removed from the study if they develop an allergic reaction to amifostine.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 35 years or older
- •Histologically confirmed Hodgkin's disease or non-Hodgkin's lymphoma receiving radiation therapy to the head and neck area.
- •Involvement of one or more of the following sites: cervical node, supraclavicular node, pre-auricular node, submental node, any salivary glands, any parts of the oral cavity, or any parts of the oropharynx.
排除标准
- •Prior history of head and neck malignancies
- •Prior radiation therapy to the head and neck region
- •Patients with stage I Hodgkin's disease receiving radiation therapy alone
- •Pregnant or lactating women
- •Myocardial infarction within the 6 months of enrollment
- •Clinically evident pulmonary insufficiency, except for patients with exertional dyspnea related to chest tumor itself.
研究组 & 干预措施
Group 1
Amifostine plus radiation therapy
干预措施: Amifostine (Drug)
Group 1
Amifostine plus radiation therapy
干预措施: Radiation Therapy (Radiation)
Group 2
Radiation therapy alone
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
时间窗: 2 years
次要结局
- To determine the quality-of-life of patients receiving radiation therapy and amifostine
- to determine the safety of amifostine(2 years)