NCT00905658Unknown2 期
Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Quality of life (QLQ-C30)
研究概览
简要总结
RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment.
PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.
详细描述
OBJECTIVES:
Primary
- Measure quality of life (QLQ-C30) at week 18 in patients with metastatic gynecological cancer receiving systematic nutritional supplements during first-line chemotherapy.
Secondary
- Study the maintenance or improvement of intake and nutritional status.
- Study the quality of life during chemotherapy.
- Evaluate tolerance and compliance to treatment with nutritional supplements.
- Evaluate the feasibility of and the tolerance to chemotherapy.
- Measure the overall survival over 18 weeks.
- Analyze the cost-effectiveness of different strategies of nutritional care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Quality of life (QLQ-C30)
次要结局
未报告次要终点
研究者
研究点 (2)
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