title: L-carnitine supplementation for the management of fatigue in patients with cancer: an eastern cooperative oncology group phase III, randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  L-carnitine, a popular complementary and alternative medicine product, is used by patients with cancer for the treatment of fatigue, the most commonly reported symptom in this patient population. The purpose of this study was to determine the efficacy of L-carnitine supplementation as a treatment for fatigue in patients with cancer.
  
  
  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.
  
  
  CONCLUSIONS
  Four weeks of 2 g of L-carnitine supplementation did not improve fatigue in patients with invasive malignancies and good performance status.
authors.affiliation: Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York, NY 10003, USA. rcruciani@chpnet.org
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Cruciani
authors.forename: Jenny J
authors.initials: JJ
authors.lastname: Zhang
authors.forename: Judith
authors.initials: J
authors.lastname: Manola
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Bilal
authors.initials: B
authors.lastname: Ansari
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Fisch
mesh_terms: D002331:Carnitine / Q000008:administration & dosage* / Q000097:blood; D000529:Complementary Therapies / Q000379:methods*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005221:Fatigue / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000097:blood / Q000150:complications* / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D002331:Carnitine