A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 472
- 试验地点
- 497
- 主要终点
- Lean body mass
研究概览
简要总结
RATIONALE: Nutritional supplements may help prevent loss of appetite, weight loss, and fatigue in patients with advanced cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two nutritional supplements in preventing loss of appetite, weight loss, and fatigue in patients who have stage III or stage IV solid tumors.
详细描述
OBJECTIVES:
- Compare the change in lean body mass of patients treated with Juven® vs a non-Juven® supplement.
- Compare the change in fatigue and quality of life of patients treated with these supplements.
- Compare the results of plethysmography, bioimpedance, and skinfold measurement in patients treated with these supplements.
- Compare the weight change in patients treated with these supplements.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to primary disease site (lung vs others), concurrent chemotherapy (yes vs no), evidence of metastases (yes vs no), and degree of weight loss (2-5% vs 6-10%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral Juven® supplement twice daily for 8 weeks.
- Arm II: Patients receive oral non-Juven® supplement twice daily for 8 weeks. All patients undergo lean body mass measurement (to include multiple body composition and weight change) and fatigue and quality of life assessments at baseline and then at 4 and 8 weeks.
PROJECTED ACCRUAL: A total of 468 patients (234 per treatment arm) will be accrued for this study within 16 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 120 Years（Child, 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
结局指标
主要结局
Lean body mass
时间窗: Study entry to 8 weeks
次要结局
- Quality of Life(Study entry to 8 weeks)
- Body weight(Study entry to 8 weeks)
- Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement(Study entry to 8 weeks)
- Fatigue(Study entry to 8 weeks)