Clinical Trial: Levocarnitine in Treating Fatigue in Cancer Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer
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.
Detailed Summary:
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
Sponsor: ECOG-ACRIN Cancer Research Group
Current Primary Outcome: 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 ]
Original Primary Outcome:
Current Secondary Outcome:
- Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks [ Time Frame: assessed at baseline and 4 weeks after randomization ]Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline.
- Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline [ Time Frame: assessed at baseline and 4 weeks after randomization ]Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline.
- Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks [ Time Frame: assessed at baseline and 4 weeks after randomization ]Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline.
- Prevalence of Carnitine Deficiency at 4 Weeks [ Time Frame: assessed at 4 weeks after randomization ]Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine > 0.4 μmol/L or free carnitine < 35 μmol/L for males and < 25 μmol/L for females.
- Proportion of Patients With Stable or Improving Performance Status at 4 Weeks [ Time Frame: assessed at baseline and 4 weeks after randomization ]Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS.
Original Secondary Outcome:
Information By: Eastern Cooperative Oncology Group
Dates:
Date Received: September 7, 2004
Date Started: November 2005
Date Completion:
Last Updated: May 3, 2016
Last Verified: May 2016