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Levocarnitine in Treating Fatigue in Cancer Patients

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careCompleted18 and overNCI, OtherCDR0000384087
ECOG-E4Z02, E4Z02, NCT00091169

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

National Cancer Institute

Ricardo CrucianiStudy Chair

Russell K. Portenoy

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00091169
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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