Status:
COMPLETED
Levocarnitine in Treating Fatigue in Cancer Patients
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary Objective: * Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the management of fatigue in patients with cancer. Secondary Objectives: * Asses...
Eligibility Criteria
Inclusion
- 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 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) question "I feel fatigued"
- Age 18 and over
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-3
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
Exclusion
- Brain metastases
- Hemoglobin \< 9 g/dL, taken \<=4 weeks prior to registration
- Severe, uncontrolled liver disease
- Evidence of severely compromised renal function including any 1 of the following:
- Renal failure
- End stage renal disease
- Ongoing renal dialysis
- Severe, uncontrolled cardiovascular disease
- Severe, uncontrolled pulmonary disease
- Pregnant or nursing
- History of seizures
- Known sensitivity to carnitine
- Delirium
- Nausea \> grade 1
- Taking any form of levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine within 2 months prior to registration
Key Trial Info
Start Date :
December 16 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00091169
Start Date
December 16 2005
End Date
May 1 2011
Last Update
July 5 2023
Active Locations (116)
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1
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
2
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States, 94305
3
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States, 06810
4
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040