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Levocarnitine in Treating Fatigue in Cancer Patients

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

Summary

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.

Description

OBJECTIVES:

Primary

- Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the management of fatigue in patients with cancer.

Secondary

- 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

Conditions

Fatigue

Intervention

levocarnitine, placebo

Location

Veterans Affairs Medical Center - Palo Alto
Palo Alto
California
United States
94304

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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

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