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Levocarnitine in Treating Fat...

Levocarnitine in Treating Fatigue in Cancer Patients

Last Updated: 2023-07-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-16

Study Completion Date

2011-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fatigue Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm I

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

Group Type EXPERIMENTAL

levocarnitine

Intervention Type DIETARY_SUPPLEMENT

Given orally

Arm II

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

Interventions

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levocarnitine

Given orally

Intervention Type DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Cruciani, MD, PhD

Role: STUDY_CHAIR

Beth Israel Medical Center - Petrie Division

Russell K. Portenoy, MD

Role: STUDY_CHAIR

Beth Israel Medical Center - Petrie Division

Locations

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Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, United States

Site Status

Stanford Comprehensive Cancer Center - Stanford

Stanford, California, United States

Site Status

Praxair Cancer Center at Danbury Hospital

Danbury, Connecticut, United States

Site Status

Manchester Memorial Hospital

Manchester, Connecticut, United States

Site Status

Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center

Boca Raton, Florida, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status