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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091169 |
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 |
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Fatigue Unspecified Adult Solid Tumor, Protocol Specific |
Drug: levocarnitine Drug: 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 |
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.
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Drug: levocarnitine
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo twice daily on weeks 1-4.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
No evidence of severely compromised renal function including any 1 of the following:
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Ricardo Cruciani, MD, PhD | Beth Israel Medical Center - Petrie Division |
Investigator: | Russell K. Portenoy, MD | Beth Israel Medical Center - Petrie Division |
Study ID Numbers: | CDR0000384087, ECOG-E4Z02 |
Study First Received: | September 7, 2004 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00091169 |
Health Authority: | United States: Federal Government |
fatigue unspecified adult solid tumor, protocol specific |
Signs and Symptoms Fatigue Carnitine |
Vitamin B Complex Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Pharmacologic Actions |