Levocarnitine in Treating Fatigue in Cancer Patients

2014-08-27 03:54:05 | BioPortfolio


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.




- 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.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care




levocarnitine, placebo


Veterans Affairs Medical Center - Palo Alto
Palo Alto
United States




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:54:05-0400

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Medical and Biotech [MESH] Definitions

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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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