Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Number of Patients With Each Degree of Swallowing Dysfunction
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer.
PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
详细描述
OBJECTIVES:
Primary
- To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine
Secondary
- To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
- To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
- To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm IA
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
干预措施: therapeutic dietary intervention (Procedure)
Arm IB
Patients undergo SNT and low weight resistance training (LWRT).
干预措施: exercise intervention (Behavioral)
Arm IB
Patients undergo SNT and low weight resistance training (LWRT).
干预措施: therapeutic dietary intervention (Procedure)
Arm IIA
Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
干预措施: amifostine trihydrate (Drug)
Arm IIA
Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
干预措施: therapeutic dietary intervention (Procedure)
Arm IIB
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
干预措施: exercise intervention (Behavioral)
Arm IIB
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
干预措施: amifostine trihydrate (Drug)
Arm IIB
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
干预措施: therapeutic dietary intervention (Procedure)
结局指标
主要结局
Number of Patients With Each Degree of Swallowing Dysfunction
时间窗: 6 months after concurrent chemotherapy and radiation
Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment
次要结局
- Stimulated and Unstimulated Salivary Production(6 months after concurrent chemotherapy and radiation)
- Changes in the Amount and Texture of Food Consumed(at baseline, at 1 month, 3 months and 6 months post-chemoradiation)
- Changes in the Frequency and Types of Dietary Intakes(at baseline, at 1 month, 3 months and 6 months post-chemoradiation)
- Number of Patients With Oral Mucositis by Grade(6 months after concurrent chemotherapy and radiation)
研究者
Barbara Murphy, MD
Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center