NCT00091169已完成3 期
Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer
ECOG-ACRIN Cancer Research Group231 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2005年12月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 231
- 主要终点
- Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks
研究概览
简要总结
RATIONALE: Levocarnitine may help improve energy levels in cancer patients.
PURPOSE: This randomized phase III trial is studying how well levocarnitine works compared to a placebo in treating fatigue in cancer patients.
详细描述
OBJECTIVES:
Primary Objective:
- Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the management of fatigue in patients with cancer.
Secondary Objectives:
- Assess the effect of levocarnitine on pain, depression and performance status at 4 and 8 weeks of follow-up.
- Determine the prevalence of serum carnitine deficiency in patients treated with these regimens.
- Explore the association between carnitine deficiency and fatigue.
- Present the toxicity profiles of all patients.
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
- Triple (Participant, Care Provider, 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
- •Diagnosis of an invasive malignant disorder
- •Moderate to severe fatigue within the past 4 weeks, defined as a score of ≥ 2 (on a scale of 0-4) on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) question "I feel fatigued"
- •Age 18 and over
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0-3
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
排除标准
- •Brain metastases
- •Hemoglobin < 9 g/dL, taken <=4 weeks prior to registration
- •Severe, uncontrolled liver disease
- •Evidence of severely compromised renal function including any 1 of the following:
- •Renal failure
- •End stage renal disease
- •Ongoing renal dialysis
- •Severe, uncontrolled cardiovascular disease
- •Severe, uncontrolled pulmonary disease
- •Pregnant or nursing
- •History of seizures
- •Known sensitivity to carnitine
- •Nausea > grade 1
- •Taking any form of levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine within 2 months prior to registration
结局指标
主要结局
Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks
时间窗: assessed at baseline and 4 weeks after randomization
Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.
次要结局
- Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks(assessed at baseline and 4 weeks after randomization)
- Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline(assessed at baseline and 4 weeks after randomization)
- Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks(assessed at baseline and 4 weeks after randomization)
- Prevalence of Carnitine Deficiency at 4 Weeks(assessed at 4 weeks after randomization)
- Proportion of Patients With Stable or Improving Performance Status at 4 Weeks(assessed at baseline and 4 weeks after randomization)
研究者
研究点 (231)
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