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.
What this study found
L-carnitine did not improve fatigue compared with placebo in this cancer population. On the primary Brief Fatigue Inventory outcome, the change from baseline to week 4 was −0.96 with L-carnitine versus −1.11 with placebo (P = .57), and both groups improved from baseline, suggesting a placebo effect. Secondary outcomes were also negative, with no between-group differences for FACIT-F fatigue (P = .64), depression (P = .93), pain severity (P = .61), or pain interference (P = .75). Baseline carnitine deficiency did not predict benefit. Grade 5 serious adverse events were rare and did not differ…
- Study & population
- This was a phase III randomized, double-blind, placebo-controlled trial conducted across 24 ECOG-associated sites.
- Intervention
- Participants in the active arm received oral liquid L-carnitine 1 g twice daily for 4 weeks, for a total dose of 2 g/day.
- Key limitation
- The intervention period was short at 4 weeks, which may have limited the ability to detect delayed effects.
View source
Open PDFOriginal 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 efficacy of L-carnitine supplementation as a treatment for fatigue in patients with cancer. 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 Four weeks of 2 g of L-carnitine supplementation did not improve fatigue in patients with invasive malignancies and good performance status.