Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Levocarnitine in Treating Fatigue in Cancer Patients

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Completed 18 and over NCI ECOG-E4Z02 NCT00091169, E4Z02

Special Category: NCI Web site featured trial

Objectives

Primary

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

Secondary

1. Determine the prevalence of serum carnitine deficiency in patients treated with these regimens.

Entry 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

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

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

Expected Enrollment

A total of 352 patients will be accrued for this study.

Outcomes

Change in average daily fatigue as assessed by the Brief Fatigue Inventory (BFI) from baseline to 4 weeks

Prevalence of carnitine deficiency
Changes in levels of fatigue
Effect on pain and performance status at 4 and 8 weeks
Score changes in the BFI and the Brief Pain Inventory
Survival
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Ricardo Cruciani, MD, PhD, Protocol chair		Ph: 212-420-2432
Russell Portenoy, MD, Protocol co-chair		Ph: 212-844-1403 Email: rportenoy@bethisraelny.org

Related Information

Featured trial article

Registry Information
Official Title		Phase III Randomized Controlled Trial to Determine Efficacy of L-Carnitine Supplementation for Fatigue in Patients With Cancer
Trial Start Date		2005-11-03
Trial Completion Date		2007-01-24
Registered in ClinicalTrials.gov		NCT00091169
Date Submitted to PDQ		2005-12-19
Information Last Verified		2007-09-14
NCI Grant/Contract Number		CA37403, 31110

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