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.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Nov 2012
Citations:87
Influential Citations:2
Interventional (Human) Studies
81
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Methods
Phase III, randomized, double-blind, placebo-controlled multicenter trial across 24 sites. Adults with invasive malignancies and moderate-to-severe fatigue at baseline; ECOG performance status 0–3; 376 participants randomized (189 to L-carnitine, 187 to placebo). Exclusions included age <18, seizures, brain metastases, and severely compromised renal, liver, or respiratory function. Participants were treated in outpatient or inpatient settings; an open-label extension followed the blinded 4-week phase.
Intervention
L-carnitine, 1 g twice daily (2 g/day), oral, for 4 weeks.
Results
Fatigue improved in both arms from baseline to week 4 with no significant difference between L-carnitine and placebo (BFI change: -0.96 vs -1.11; P = 0.57). Plasma total carnitine increased in the L-carnitine arm (46.3 → 66.2) versus placebo (43.6 → 43.7) at week 4, confirming adherence but not translating to fatigue benefit. Secondary outcomes (FACIT-F, depression, pain) showed no significant arm differences. Baseline carnitine-deficient patients did not have improved fatigue with L-carnitine. Conclusion: Four weeks of 2 g/day L-carnitine did not improve fatigue in adults with invasive cancer and adequate performance status; routine use for cancer-related fatigue is not supported.
Limitations
Missing follow-up data for ~25–30% of participants; open-label extension may bias longer-term results; heterogeneous cancer types and treatments; only ~30% were carnitine-deficient at baseline; short blinded-treatment duration.

Abstract

PURPOSE 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...