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Completed

NCT Number: NCT00091169

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.

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Key information

Conditions

Fatigue Behavior Behavioral Symptoms Depression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Systemic carnitine deficiency Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States

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About this study

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of an invasive malignant disorder
  • Moderate to severe fatigue within the past 4 weeks, defined as a score of ≥ 2 (on a scale of 0-4) on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) question "I feel fatigued"
  • Age 18 and over
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0-3
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

Exclusion criteria

  • Brain metastases
  • Hemoglobin < 9 g/dL, taken <=4 weeks prior to registration
  • Severe, uncontrolled liver disease
  • Evidence of severely compromised renal function including any 1 of the following:
  • Renal failure
  • End stage renal disease
  • Ongoing renal dialysis
  • Severe, uncontrolled cardiovascular disease
  • Severe, uncontrolled pulmonary disease
  • Pregnant or nursing
  • History of seizures
  • Known sensitivity to carnitine
  • Delirium
  • Nausea > grade 1
  • Taking any form of levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine within 2 months prior to registration

Treatment and study plan

Levocarnitine

Dietary Supplement

Given orally

Placebo

Other

Given orally

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2011
First posted
Sep 8, 2004
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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