Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
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.
2. Assess changes in the levels of fatigue at its worst.
3. Assess the effect of levocarnitine on pain and performance status at 4 and 8 weeks of follow-up.
4. Assess score changes in the items of the Brief Fatigue Inventory and the Brief Pain Inventory.
5. Explore the association between carnitine (and acetyl levocarnitine) deficiency and fatigue and other selected covariates.
6. Present the toxicity profiles of all patients.
7. 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.

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.

Rich TA, Fisch MJ, Manola J, et al.: Analysis of cytokines in ECOG E4Z02: A phase III randomized study of l-carnitine supplementation for fatigue in patients with cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-9635, 2009.

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 Placebo-Controlled Trial to Determine Efficacy of L-Carnitine Supplementation for Fatigue in Patients With Cancer
Trial Start Date		2005-11-03
Trial Completion Date		2006-07-13
Registered in ClinicalTrials.gov		NCT00091169
Date Submitted to PDQ		2005-12-19
Information Last Verified		2008-10-28
NCI Grant/Contract Number		CA37403, 31110

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