Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034450
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-04-29
Brief Title:
Developmental Study on Fatigue in Cancer
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Developmental Study on Fatigue in Cancer
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 1727 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 610 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 gday placebo b During weeks 5-8 all patients will receive L-carnitine at a dose of 2 gday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None