Levocarnitine in Treating Fatigue in Cancer Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00091169

Run by

ECOG-ACRIN Cancer Research Group

People needed

376

Starts

2005-12-16

Expected to finish

2011-05-01

Last updated by the study team

2023-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford Comprehensive Cancer Center - Stanford — Stanford, California, United States
• Praxair Cancer Center at Danbury Hospital — Danbury, Connecticut, United States
• Manchester Memorial Hospital — Manchester, Connecticut, United States
• Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center — Boca Raton, Florida, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Eureka Community Hospital — Eureka, Illinois, United States
• Evanston Northwestern Healthcare - Evanston Hospital — Evanston, Illinois, United States
• Galesburg Clinic, PC — Galesburg, Illinois, United States
• Galesburg Cottage Hospital — Galesburg, Illinois, United States
• Mason District Hospital — Havana, Illinois, United States
• Hopedale Medical Complex — Hopedale, Illinois, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• McDonough District Hospital — Macomb, Illinois, United States
• BroMenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center — Normal, Illinois, United States
• Community Hospital of Ottawa — Ottawa, Illinois, United States
• Oncology Hematology Associates of Central Illinois, PC - Ottawa — Ottawa, Illinois, United States
• Cancer Treatment Center at Pekin Hospital — Pekin, Illinois, United States
• Proctor Hospital — Peoria, Illinois, United States
• CCOP - Illinois Oncology Research Association — Peoria, Illinois, United States
• Veterans Affairs Medical Center - Palo Alto — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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