Cruciani, R. A., Dvorkin, E., Homel, P., Culliney, B., Malamud, S., Shaiova, L., . . . Esteban-Cruciani, N. (2004). L-carnitine supplementation for the treatment of fatigue and depressed mood in cancer patients with carnitine deficiency: a preliminary analysis. Annals of the New York Academy of Sciences, 1033, 168–176.

DOI Link

Study Purpose

Carnitine is hypothesized to be key in the energy metabolism and regulation of adenosine triphosphate (ATP) promotion and a protective effect of mitochondrial metabolism. Carnitine deficits are common in cancer patients and other chronically ill persons.
 

Intervention Characteristics/Basic Study Process

L-carnitine supplementation was given in dose levels of 250 mg/day. Dose levels were planned to increase by 500 mg until the target dose of 3000 mg/day was reached.

Sample Characteristics

Of 645 adult patients, 13% met following inclusion criteria:

  • Age of at least 18 years
  • Greater than 3 month life expectancy
  • Self-reported fatigue was moderate to severe for at least one week
  • Carnitine deficiency
  • Karnofsky Performance Status (KPS) of 50% or greater.

Patients were excluded from the study if they had severe disease, brain tumor, or stroke; were unable to complete the assessment tools; had started erythropoietin within less than 3 months; had received radiotherapy or chemotherapy within one week prior to the study; or were unable to consent.

Setting

Hospice and Cancer Center

Study Design

The study used an open-label, dose-finding, safety design, with dose cohorts of three.

Measurement Instruments/Methods

  • Brief Fatigue Inventory (BFI)
  • Center for Epidemiological Studies Depression Scale (CESD)
  • Quality of sleep
  • Epworth Sleepiness Scale (ESS)
  • KPS

Results

  • Of the patients, 83% reported fatigue with a significant decrease in BFI score after one week (p = .009).
  • CESD decreased (p = 0.028).
  • ESS decreased (p = 0.015).
  • No significant change occurred in KPS.
  • Dose was safely escalated to 1750 mg/d.

Limitations

  • The study had a small sample size.
  • Hospice patients often have multiple medical problems. 
  • Three higher dose levels were not reached.
  • Treatment length was short (one week). 
  • The effect of prolonged use is unknown.
  • No monitoring of dietary carnitine was performed.
  • It is unknown if L-carnitine supplementation accelerates cancer or interferes with the effects of certain agents.

Nursing Implications

Cost of supplements and monitoring levels of L-carnitine is unknown.