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RATIONALE: Levocarnitine may help improve energy levels in cancer patients.
- Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the management of fatigue in patients with cancer.
- Determine the prevalence of serum carnitine deficiency in patients treated with these regimens.
- Assess changes in the levels of fatigue at its worst.
- Assess the effect of levocarnitine on pain and performance status at 4 and 8 weeks of follow-up.
- Assess score changes in the items of the Brief Fatigue Inventory and the Brief Pain Inventory.
- Explore the association between carnitine (and acetyl levocarnitine) deficiency and fatigue and other selected covariates.
- Present the toxicity profiles of all patients.
- Measure serum levels of the pro-inflammatory cytokines IL-1, IL-6, TNF-α, the growth factors TGF-α, EGF, NRG-1, VEGF, and triglycerides (TG) and correlate with fatigue and other oncobehavioral symptoms.
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.
- Arm I: Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
- Arm II: Patients receive oral placebo twice daily on weeks 1-4. After week 4, all patients receive oral L-carnitine twice daily on weeks 5-8.
Fatigue is assessed at baseline and then at weeks 4 and 8.
PROJECTED ACCRUAL: A total of 352 patients will be accrued for this study.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care
Veterans Affairs Medical Center - Palo Alto
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:05-0400
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