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 ]

Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.


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