Trial Information

Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of L-Carnitine Supplementation for Fatigue in Patients With Cancer

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.