Cruciani, R. A., Zhang, J. J., Manola, J., Cella, D., Ansari, B., & Fisch, M. J. (2012). 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, 30, 3864–3869.

To determine the efficacy of L-carnitine supplementation for fatigue in patients with cancer.

Patients were randomized to receive 1 g of L-carnitine liquid twice daily for four weeks or placebo.  For weeks five to eight, all patients received L-carnitine in an open-label extension. Outcome measures were assessed at baseline and at weeks four and eight.

• In total, 237 patients (42% male, 58% female) were included.
• Age was not reported.
• Disease types were not reported.
• About 80% of patients were currently receiving chemotherapy and 18% were receiving radiotherapy. Slightly less than one-third were receiving antidepressants. 

• Multisite 
• Outpatient 
• United States

Patients were undergoing the active antitumor treatment phase of care.

The study was a randomized, double-blind, placebo-controlled, phase III trial followed by a four-week open-label extension.

• Brief Fatigue Inventory (BFI)
• Center for Epidemiologic Studies Depression Scale (CESD)
• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
• Eastern Cooperative Oncology Group (ECOG) performance status
• Blood sample analysis for plasma carnitine and acylcarnitine
   

The group receiving L-carnitine had a greater increase in plasma carnitine levels. At week four, one-third of those on placebo were carnitine-deficient, compared to 11% of those who were receiving carnitine (p ≤ 0.001). BFI scores improved significantly in both groups by approximately one point (p < 0.001). There were no differences between groups in fatigue, depression, or pain. Over time, there was a significant decrease in the proportion of patients with severe fatigue, pain, and depression; however, there were no significant differences between groups. There were few high-grade toxicities. In one patient, the cause of death was possibly related to treatment.

Supplementation of 1 g of L-carnitine did not improve fatigue, pain, or depression in these patients.

Of the patients, 25% to 30% had missing outcome data; however, power analysis showed that the sample size was sufficient.

The findings showed that dietary supplementation with L-carnitine did not improve fatigue, depression, or pain in patients with cancer. Nurses can advise patients that this approach has not been shown to be helpful, as these results provide strong evidence that L-carnitine is not effective for these symptoms.