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Developmental Study on Fatigue in Cancer

Phase 2
18 Years
Not Enrolling

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Trial Information

Developmental Study on Fatigue in Cancer

Fatigue is the most frequently reported symptom in patients with cancer. The causes of
fatigue are multifactorial and include the disease itself, antineoplastic therapies, anemia,
depression, and malnutrition. Our preliminary data suggest that micronutrient deficiencies,
specifically carnitine deficiency, may be an important factor in fatigue. Carnitine plays a
major role in energy metabolism. Systemic depletion is characterized by weight loss,
fatigue, muscle weakness, decreased tolerance to metabolic stress, and cardiomyopathy. We
found deficiency of the micronutrient carnitine in 17/27 patients with cancer. Symptoms of
fatigue and functional status improved significantly in those patients who received oral
L-carnitine supplementation. In addition, we observed similar results in 6/10 patients with
end stage AIDS presenting with carnitine deficiency. Objectives: a) To determine the effect
of L-carnitine therapy on symptoms of fatigue in patients with terminal cancer and serum
carnitine deficiency, and b) to determine the effect of L-carnitine therapy on performance
status, cognitive function, mood, quality of life, and motor activity in these patients.
Study Design: We propose to conduct a Phase Il developmental randomized double-blind
placebo-controlled study to determine the effect of the micronutrient L-carnitine on fatigue
and other outcomes in patients with terminal cancer. A sample of 130 patients with terminal
cancer, fatigue and serum carnitine deficiency will be recruited into the intervention
study. At the first visit, the patients will receive a baseline assessment of fatigue,
performance status, cognitive function, mood, and quality of life and motor activity. a)
During weeks 1-4, patients will be randomized to receive L-carnitine, 2 g/day, placebo. b)
During weeks 5-8, all patients will receive L-carnitine at a dose of 2 g/day, for a period
of 4 weeks. Measures will be repeated at 48 hs, 2 weeks, 4 weeks and 8 weeks. The primary
endpoint will be change in fatigue at 4 weeks. Analysis will evaluate group differences in
the primary endpoint and other outcomes. An interim analysis will be done once 15 patients
have been observed in each group at 4 weeks. Paired and unpaired data analyses between
groups will be conducted with the assistance of a statistician.

Inclusion Criteria


- Patients with diagnosis of cancer and estimated life expectancy of less than 6

- Patients who have undergone antineoplastic therapy which may worsen fatigue or
promote carnitine deficiency will be eligible if completed the therapy more than 90
days prior to beginning the study.


- Uncontrolled or severe cardiovascular, pulmonary, or renal disease.

- Patients with encephalopathy or psychiatric disorder sufficiently severe to impair
completion of the questionnaire.

- Treatment or replacement therapy with any form of carnitine less than 12 months prior
to enrollment.

- Known sensitivity to carnitine.

- History of seizures or stroke.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Ricardo A. Cruciani, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Medical Center, Department of Pain Medicine and Palliative Care


United States: Federal Government

Study ID:

R21 AT001025-01



Start Date:

January 2002

Completion Date:

August 2004

Related Keywords:

  • Neoplasms
  • Terminal Cancer
  • Neoplasms



Beth Israel Medical Center New York, New York  10003