Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT00091169
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2004-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Levocarnitine in Treating Fatigue in Cancer Patients
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
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 1:1 ratio.
* Arm I (levocarnitine): Patients receive oral levocarnitine (L-carnitine) twice daily (2000 mg/day) on weeks 1-4.
* Arm II (placebo): Patients receive oral placebo twice daily (2000 mg/day) on weeks 1-4.
The dose was titrated over a 2-day period (i.e. 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 1:1 ratio.
* Arm I (levocarnitine): Patients receive oral levocarnitine (L-carnitine) twice daily (2000 mg/day) on weeks 1-4.
* Arm II (placebo): Patients receive oral placebo twice daily (2000 mg/day) on weeks 1-4.
The dose was titrated over a 2-day period (i.e. 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| E4Z02 | OTHER | Eastern Cooperative Oncology Group | View | |
| U10CA023318 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000384087 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |