Abstract | PURPOSE: PATIENTS AND METHODS: In this double-blind, placebo-controlled trial, patients with invasive malignancies and fatigue were randomly assigned to either 2 g/d of L-carnitine oral supplementation or matching placebo. The primary end point was the change in average daily fatigue from baseline to week 4 using the Brief Fatigue Inventory (BFI). RESULTS: Three hundred seventy-six patients were randomly assigned to treatment with L-carnitine supplementation or placebo. L-carnitine supplementation resulted in significant carnitine plasma level increase by week 4. The primary outcome, fatigue, measured using the BFI, improved in both arms compared with baseline ( L-carnitine: -0.96, 95% CI, -1.32 to -0.60; placebo: -1.11, 95% CI -1.44 to -0.78). There were no statistically significant differences between arms (P = .57). Secondary outcomes, including fatigue measured by the Functional Assessment of Chronic Illness Therapy- Fatigue instrument, depression, and pain, did not show significant difference between arms. A separate analysis of patients who were carnitine-deficient at baseline did not show statistically significant improvement in fatigue or other outcomes after L-carnitine supplementation. CONCLUSION:
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Authors | Ricardo A Cruciani, Jenny J Zhang, Judith Manola, David Cella, Bilal Ansari, Michael J Fisch |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 30
Issue 31
Pg. 3864-9
(Nov 01 2012)
ISSN: 1527-7755 [Electronic] United States |
PMID | 22987089
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
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Topics |
- Carnitine
(administration & dosage, blood)
- Complementary Therapies
(methods)
- Dietary Supplements
- Double-Blind Method
- Fatigue
(blood, drug therapy, etiology)
- Female
- Humans
- Male
- Neoplasms
(blood, complications, drug therapy)
- Treatment Outcome
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