CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 376 enrolled
Drug / intervention
levocarnitine +1 moredietary
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Diagnosis of invasive malignant disorder
  • ✓Moderate to severe fatigue within past 4 weeks (FACIT-F score ≥2)
  • ✓Age 18 and over
  • ✓ECOG performance status 0-3
Key exclusion· 11
  • ✕Brain metastases
  • ✕Hemoglobin <9 g/dL (within ≤4 weeks prior to registration)
  • ✕Severe, uncontrolled liver disease
  • ✕Severely compromised renal function (renal failure, end-stage renal disease, or ongoing dialysis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00091169
NCT00091169Phase 3Completed
CompareCT.gov

Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer

ECOG-ACRIN Cancer Research Group·interventional·Posted Sep 8, 2004·Updated Jul 5, 2023

In Brief

A Phase 3 clinical trial evaluating levocarnitine and placebo for Fatigue and Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 376 participants across 116 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2004
Enrollment StartDec 16, 2005
Primary CompletionMar 1, 2008
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 21.8 years ago

Interventions

levocarnitinedietary

Given orally

placeboother

Given orally