Levocarnitine in Treating Fatigue in Cancer Patients

What Was Tested

The trial (phase 3) is built around L-Carnitine.

It had two arms (groups): Arm I (experimental) and Arm II (placebo comparator).

Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.

Patients receive oral placebo twice daily on weeks 1-4.

The registry classes the interventions as dietary supplement and other.

More on the Plan

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).

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.

Who Took Part

The registry lists 376 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of an invasive malignant disorder. Age 18 and over. Negative pregnancy test.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: brain metastases; severe, uncontrolled liver disease; evidence of severely compromised renal function including any 1 of the following:.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2005-12-16 with completion listed for 2008-03.

It ran at 116 sites in United States (116).

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks (time frame: assessed at baseline and 4 weeks after randomization).

It also tracked 5 secondary outcomes, for example Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks, Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline, Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks and Prevalence of Carnitine Deficiency at 4 Weeks.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 376 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the L-Carnitine compound page, all human trials.