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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014