Cruciani, R. A., Dvorkin, E., Homel, P., Malamud, S., Culliney, B., Lapin, J., . . . Esteban-Cruciani, N. (2006). Safety, tolerability and symptom outcomes associated with L-carnitine supplementation in patients with cancer, fatigue, and carnitine deficiency: a phase I/II study. Journal of Pain and Symptom Management, 32, 551–559.

Carnitine deficiency is among the many metabolic disturbances that may contribute to fatigue in patients with cancer. Administration of exogenous L-carnitine may hold promise as a treatment for this symptom. Carnitine was prepared by the institutional pharmacy at a concentration of 1 g/mL. The drug was administered in two daily doses for seven days. After the intervention period, patients were allowed to continue L-carnitine supplementation if desired. Patient outcomes were evaluated at baseline and on day seven.

• In total, 27 patients (37% female) with advanced cancer were included.
• Mean age was 59.7 years.
• The majority of patients were Caucasian (59%).
• The most common diagnosis was breast cancer (22%).
• Most patients reported severe fatigue (70%), and all were carnitine-deficient.
• Patients were excluded from the study if they had hemoglobin levels less than 9 g/dL, had increased risk of seizure or heart failure, were receiving current treatment (chemotherapy, radiotherapy, or recombinant erythropoietin), or had renal insufficiency.

Beth Israel Medical Center Continuum Hospice Care, Jacob Perlow Hospice, or the Cancer Center

Patients were undergoing the active treatment phase of care.

The study was an open-label, phase I/II clinical trial.

Brief Fatigue Inventory (BFI)

Patients who received the L-carnitine intervention experienced a significant decline in fatigue (p < 0.001) as BFI scores decreased from baseline (66.1 [standard deviation (SD) = 12]) to one week after treatment to (39.7 [SD = 26]).

• Of the 85 patients who were eligible for study, 47 elected not to participate, the most common reason being that patients were interested in trials that aimed to treat their condition and were less interested in symptom management studies.
• The study lacked a neutral comparison group.
• The assessment of side effects did not rely on validated measures, and a range of potential safety measurements, such as repeated liver function tests, were not performed.