- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034450
Developmental Study on Fatigue in Cancer
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment
140
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10003
- Beth Israel Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ricardo A. Cruciani, MD, PhD, Beth Israel Medical Center, Department of Pain Medicine and Palliative Care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Study Completion
August 1, 2004
Study Registration Dates
First Submitted
April 29, 2002
First Submitted That Met QC Criteria
April 29, 2002
First Posted (Estimate)
April 30, 2002
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT001025-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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