Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 220
- 主要终点
- Percentage of patients who gain weight over 1 month
研究概览
简要总结
RATIONALE: It is not yet known whether the supplement creatine is effective in increasing weight and improving appetite and quality of life in patients who have cancer.
PURPOSE: This randomized phase III trial is studying how well creatine works in increasing weight and improving appetite and quality of life in patients with weight loss caused by cancer.
详细描述
OBJECTIVES:
- Compare weight-gain effects of creatine vs placebo in patients with cancer-associated weight loss and/or anorexia.
- Determine the effect of these regimens on quality of life in these patients.
- Compare the toxic effects of these regimens in these patients.
- Compare survival rates of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to primary cancer type (lung vs gastrointestinal vs other), weight loss severity (< 10 lbs vs ≥10 lbs), age (< 50 years vs ≥ 50 years), planned concurrent chemotherapy (yes vs no), gender, and prognosis. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral creatine daily.
- Arm II: Patients receive oral placebo daily. In both arms, treatment continues in the absence of unacceptable toxicity as long as treatment is considered beneficial.
Patients are followed every 6 months for up to 5 years.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed cancer other than primary brain cancer
- •Considered incurable with available therapies
- •History of weight loss ≥ 5 lbs in 2 months or fewer AND/OR estimated intake of < 20 cal/kg daily
- •Determination by attending physician that weight gain would benefit patient
- •Perception by patient that weight loss is a problem
- •No symptomatic or untreated brain metastases
- •No clinical evidence of ascites
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Creatinine normal
- •Cardiovascular
- •No poorly controlled congestive heart failure
- •No poorly controlled hypertension
- •Able to reliably receive oral medication
- •Must be alert and mentally competent
- •No known obstruction of the alimentary tract, malabsorption, or intractable vomiting
- •No diabetes that is controlled by insulin
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •Concurrent chemotherapy allowed
- •Endocrine therapy
- •No other concurrent adrenal corticosteroids, androgens, or progestational agents within 30 days after study entry
- •Concurrent short-term dexamethasone for chemotherapy-associated emesis is allowed
- •Concurrent inhalant, topical, or optical steroids allowed
- •Radiotherapy
- •No concurrent radiotherapy to the bowel or stomach
- •Other concurrent radiotherapy allowed
- •No prior creatine use
- •No concurrent tube feedings or parenteral nutrition
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive oral placebo daily.
干预措施: placebo (Other)
Arm I
Patients receive oral creatine daily.
干预措施: creatine monohydrate (Dietary Supplement)
结局指标
主要结局
Percentage of patients who gain weight over 1 month
时间窗: 1 month
次要结局
- Overall survival(Up to 5 years)
- Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month(1 month)
- Percentage of patients who manifest stability in appetite(Up to 5 years)
- Incidence of treatment-related toxicity(Up to 5 years)
- Quality of life(Up to 5 years)