Levocarnitine in Treating Fatigue in Cancer Patients
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.
|Fatigue Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: levocarnitine Other: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer|
- 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.
- 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.
|Study Start Date:||November 2005|
|Study Completion Date:||May 2011|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
Dietary Supplement: levocarnitine
Placebo Comparator: Arm II
Patients receive oral placebo twice daily on weeks 1-4.
- Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the management of fatigue in patients with cancer.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091169
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|Study Chair:||Ricardo Cruciani, MD, PhD||Beth Israel Medical Center - Petrie Division|
|Study Chair:||Russell K. Portenoy, MD||Beth Israel Medical Center - Petrie Division|