Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer
Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer
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.
OBJECTIVES:
Primary Objective:
Secondary Objectives:
Correlative Objective:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, ECOG performance status (0-1 vs 2-3), and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms in a 1:1 ratio.
The dose was titrated over a 2-day period (i.e. two 500 mg doses the first day and two 1000 mg doses the second day) to avoid gastrointestinal side effects. Patients then continued to receive two daily doses of 1000 mg on days 3 to 28.
After week 4, all patients (on both arms) receive open-label oral L-carnitine twice daily on weeks 5-8 (extension phase) administered in the same fashion as during the first 4 weeks. For patients who had received a dose modification during weeks 1 to 4, they received the same reduced dose during the extension phase (without titration)
Fatigue, pain, and depression are assessed at baseline and then at weeks 4 and 8.
PROJECTED ACCRUAL: A total of 352 patients will be accrued for this study.
Inclusion Criteria:
Exclusion Criteria:
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:
Severe, uncontrolled cardiovascular disease
Severe, uncontrolled pulmonary disease
Pregnant or nursing
History of seizures
Known sensitivity to carnitine
Delirium
Nausea > grade 1
Taking any form of levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine within 2 months prior to registration
Boca Raton, Florida 33486, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
La Porte, Indiana 46350, United States
Dearborn, Michigan 48123-2500, United States
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