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.

Condition	Treatment or Intervention	Phase
Fatigue unspecified adult solid tumor, protocol specific	Drug: levocarnitine  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: fatigue assessment/management  Procedure: nutritional supplementation  Procedure: supportive care/therapy	Phase III

Further Study Details: 

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.

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 192 patients (96 per treatment arm) will be accrued for this study within 2.5 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of an invasive malignant disorder
• Moderate to severe fatigue within the past 4 weeks, defined as a score of ≥ 4 (on a scale of 0-10) to a specific question on the Brief Fatigue Inventory questionnaire
• 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

• Not specified

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 4 weeks since prior levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine

Study chairs or principal investigators

Ricardo Cruciani, MD, PhD,  Study Chair,  Beth Israel Medical Center - Petrie Division   
Russell K. Portenoy, MD,  Beth Israel Medical Center - Petrie Division   

Study ID Numbers:  CDR0000384087; ECOG-E4Z02; NCT00091169
Record last reviewed:  September 2004
Last Updated:  February 24, 2005
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00091169
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08