Developmental Study on Fatigue in Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-08-31

Brief Summary

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L-carnitine is a supplement (type of vitamin) that has been suggested to be decreased in patients with cancer. We will identify patients that have terminal cancer and fatigue. The purpose of this study is to determine if L-carnitine replacement improves fatigue in cancer patients with L-carnitine deficiency.

Detailed Description

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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.

Conditions

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Neoplasms

Keywords

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Terminal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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L-carnitine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with diagnosis of cancer and estimated life expectancy of less than 6 months.
* 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.

Exclusion:

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ricardo A. Cruciani, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Beth Israel Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT001025-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00060034

Identifier Type: -

Identifier Source: nct_alias