Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) Versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement Versus Both for the Treatment of Cancer Cachexia and Anorexia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 429
- 试验地点
- 44
- 主要终点
- Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite)
研究概览
简要总结
RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite.
PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
详细描述
OBJECTIVES:
- Compare the appetite-stimulating properties of megestrol vs an eicosapentaenoic acid-enriched nutritional supplement vs both, in terms of patient weight, rate of weight change, and appetite, in patients with cancer-related cachexia and anorexia.
- Determine the effect of these regimens on nausea and vomiting in these patients.
- Assess quality of life in patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Compare overall survival of patients treated with these regimens.
- Correlate interleukin-6 concentration changes with appetite and weight changes in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to primary cancer (lung vs gastrointestinal vs other), severity of weight loss in the past 2 months (less than 10 pounds vs 10 pounds or more), planned concurrent chemotherapy (yes vs no), age (under 50 vs 50 and over), and prognosis (good vs bad vs unsure). Patients are randomized to 1 of 3 treatment arms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 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
megestrol + placebo
Patients receive oral megestrol once daily and oral placebo twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial.
Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment.
Patients are followed every 6 months for 5 years.
干预措施: megestrol acetate (Drug)
megestrol + placebo
Patients receive oral megestrol once daily and oral placebo twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial.
Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment.
Patients are followed every 6 months for 5 years.
干预措施: placebo (Other)
eicosapentaenoic acid + placebo
Patients receive oral placebo once daily and an eicosapentaenoic acid (EPA)-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial.
Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment.
Patients are followed every 6 months for 5 years.
干预措施: eicosapentaenoic acid (Dietary Supplement)
eicosapentaenoic acid + placebo
Patients receive oral placebo once daily and an eicosapentaenoic acid (EPA)-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial.
Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment.
Patients are followed every 6 months for 5 years.
干预措施: placebo (Other)
megestrol + eicosapentaenoic acid
Patients receive oral megestrol once daily and an EPA-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial.
Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment.
Patients are followed every 6 months for 5 years.
干预措施: eicosapentaenoic acid (Dietary Supplement)
megestrol + eicosapentaenoic acid
Patients receive oral megestrol once daily and an EPA-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial.
Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment.
Patients are followed every 6 months for 5 years.
干预措施: megestrol acetate (Drug)
结局指标
主要结局
Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite)
时间窗: Up to 5 years
次要结局
- Assess quality of life(Up to 5 years)
- Overall survival(Up to 5 years)