Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of an invasive malignant disorder

• Moderate to severe fatigue within the past 4 weeks, defined as a score of ≥ 2 (on a scale of 0-4) on the FACIT-F question "I feel fatigued"

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin ≥ 9 g/dL

Hepatic

• No severe, uncontrolled liver disease

Renal

• No evidence of severely compromised renal function including any 1 of the following:

• Renal failure

• End stage renal disease

• Ongoing renal dialysis

Cardiovascular

• No severe, uncontrolled cardiovascular disease

Pulmonary

• No severe, uncontrolled pulmonary disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No history of seizures

• No known sensitivity to carnitine

• No delirium

• No nausea > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 2 months since prior levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Ricardo Cruciani

Study Chair

Russell K. Portenoy

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00091169
Information obtained from ClinicalTrials.gov on December 05, 2012