Levocarnitine in Treating Fatigue in Cancer Patients - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00091169

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 III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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:

MedlinePlus related topics: Cancer Dietary Supplements

Drug Information available for: Carnitine

U.S. FDA Resources

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
Arm I: Experimental Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.	Dietary Supplement: levocarnitine Given orally
Arm II: Placebo Comparator 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

National Cancer Institute (NCI)

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

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:	Coalition of National Cancer Cooperative Groups ( Robert L. Comis )
Study ID Numbers:	CDR0000384087, ECOG-E4Z02
Study First Received:	September 7, 2004
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00091169 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

fatigue
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Signs and Symptoms
Vitamin B Complex
Fatigue
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions
Carnitine

ClinicalTrials.gov processed this record on November 22, 2009