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Phase III Randomized Study of Levocarnitine (L-carnitine) for the Management of Fatigue in Cancer Patients
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Published Results Trial Contact Information Related Information Registry Information
Alternate Title
Levocarnitine in Treating Fatigue in Cancer Patients
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Supportive care | Completed | 18 and over | ECOG-E4Z02 NCT00091169, E4Z02 |
Special Category:
NCI Web site featured trial 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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery Other - More than 2 months since prior levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic 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
Expected Enrollment 352A total of 352 patients will be accrued for this study. Outcomes Primary Outcome(s)Change in average daily fatigue as assessed by the Brief Fatigue Inventory (BFI) from baseline to 4 weeks
Secondary Outcome(s)Prevalence of carnitine deficiency Changes in levels of fatigue Effect on pain and performance status at 4 and 8 weeks Score changes in the BFI and the Brief Pain Inventory Survival Toxicity
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. Published ResultsRich 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.
Trial Contact Information
Trial Lead Organizations Eastern Cooperative Oncology Group  |  |  | | Ricardo Cruciani, MD, PhD, Protocol chair |  | |  | | Russell Portenoy, MD, Protocol co-chair |  | |  |
Related Information Featured trial article
| Registry Information |  | | Official Title | | Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of L-Carnitine Supplementation for Fatigue in Patients With Cancer |  | | Trial Start Date | | 2005-11-03 |  | | Trial Completion Date | | 2006-07-13 |  | | Registered in ClinicalTrials.gov | | NCT00091169 |  | | Date Submitted to PDQ | | 2005-12-19 |  | | Information Last Verified | | 2008-10-28 |  | | NCI Grant/Contract Number | | CA37403, 31110 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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