Levocarnitine in Treating Fatigue in Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00091169
First received: September 7, 2004
Last updated: October 26, 2012
Last verified: October 2008
  Purpose

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 Intervention Phase
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: levocarnitine
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of L-Carnitine Supplementation for Fatigue in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in average daily fatigue as assessed by the Brief Fatigue Inventory (BFI) from baseline to 4 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of carnitine deficiency [ Designated as safety issue: No ]
  • Changes in levels of fatigue [ Designated as safety issue: No ]
  • Effect on pain and performance status at 4 and 8 weeks [ Designated as safety issue: No ]
  • Score changes in the BFI and the Brief Pain Inventory [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: No ]

Estimated Enrollment: 352
Study Start Date: November 2005
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
Dietary Supplement: levocarnitine
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo twice daily on weeks 1-4.
Other: placebo
Given orally

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091169

  Show 116 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Ricardo Cruciani, MD, PhD Beth Israel Medical Center - Petrie Division
Investigator: Russell K. Portenoy, MD Beth Israel Medical Center - Petrie Division
  More Information

Additional Information:
Publications:
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.

Responsible Party: Robert L. Comis, Coalition of National Cancer Cooperative Groups
ClinicalTrials.gov Identifier: NCT00091169     History of Changes
Other Study ID Numbers: CDR0000384087, ECOG-E4Z02
Study First Received: September 7, 2004
Last Updated: October 26, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
fatigue
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014