Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091169
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2004-09-07
Brief Title:
Levocarnitine in Treating Fatigue in Cancer Patients
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Levocarnitine may help improve energy levels in cancer patients
PURPOSE This randomized phase III trial is studying how well levocarnitine works compared to a placebo in treating fatigue in cancer patients
PURPOSE This randomized phase III trial is studying how well levocarnitine works compared to a placebo in treating fatigue in cancer patients
Detailed Description:
OBJECTIVES
Primary Objective
Compare the efficacy of levocarnitine L-carnitine supplementation vs placebo for the management of fatigue in patients with cancer
Secondary Objectives
Assess the effect of levocarnitine on pain depression and performance status at 4 and 8 weeks of follow-up
Determine the prevalence of serum carnitine deficiency in patients treated with these regimens
Explore the association between carnitine deficiency and fatigue
Present the toxicity profiles of all patients
Correlative Objective
Measure serum levels of the pro-inflammatory cytokines and growth factors and correlate with fatigue and other onco-behavioral symptoms
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to gender ECOG performance status 0-1 vs 2-3 and concurrent chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms in a 11 ratio
Arm I levocarnitine Patients receive oral levocarnitine L-carnitine twice daily 2000 mgday on weeks 1-4
Arm II placebo Patients receive oral placebo twice daily 2000 mgday on weeks 1-4
The dose was titrated over a 2-day period ie two 500 mg doses the first day and two 1000 mg doses the second day to avoid gastrointestinal side effects Patients then continued to receive two daily doses of 1000 mg on days 3 to 28
After week 4 all patients on both arms receive open-label oral L-carnitine twice daily on weeks 5-8 extension phase administered in the same fashion as during the first 4 weeks For patients who had received a dose modification during weeks 1 to 4 they received the same reduced dose during the extension phase without titration
Fatigue pain and depression are assessed at baseline and then at weeks 4 and 8
PROJECTED ACCRUAL A total of 352 patients will be accrued for this study
Primary Objective
Compare the efficacy of levocarnitine L-carnitine supplementation vs placebo for the management of fatigue in patients with cancer
Secondary Objectives
Assess the effect of levocarnitine on pain depression and performance status at 4 and 8 weeks of follow-up
Determine the prevalence of serum carnitine deficiency in patients treated with these regimens
Explore the association between carnitine deficiency and fatigue
Present the toxicity profiles of all patients
Correlative Objective
Measure serum levels of the pro-inflammatory cytokines and growth factors and correlate with fatigue and other onco-behavioral symptoms
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to gender ECOG performance status 0-1 vs 2-3 and concurrent chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms in a 11 ratio
Arm I levocarnitine Patients receive oral levocarnitine L-carnitine twice daily 2000 mgday on weeks 1-4
Arm II placebo Patients receive oral placebo twice daily 2000 mgday on weeks 1-4
The dose was titrated over a 2-day period ie two 500 mg doses the first day and two 1000 mg doses the second day to avoid gastrointestinal side effects Patients then continued to receive two daily doses of 1000 mg on days 3 to 28
After week 4 all patients on both arms receive open-label oral L-carnitine twice daily on weeks 5-8 extension phase administered in the same fashion as during the first 4 weeks For patients who had received a dose modification during weeks 1 to 4 they received the same reduced dose during the extension phase without titration
Fatigue pain and depression are assessed at baseline and then at weeks 4 and 8
PROJECTED ACCRUAL A total of 352 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E4Z02 | OTHER | None | None |
| U10CA023318 | NIH | None | None |
| CDR0000384087 | REGISTRY | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA023318 |