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

Phase 3
18 Years
Not Enrolling
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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



- Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the
management of fatigue in patients with cancer.


- Determine the prevalence of serum carnitine deficiency in patients treated with these

- Assess changes in the levels of fatigue at its worst.

- Assess the effect of levocarnitine on pain and performance status at 4 and 8 weeks of

- Assess score changes in the items of the Brief Fatigue Inventory and the Brief Pain

- Explore the association between carnitine (and acetyl levocarnitine) deficiency and
fatigue and other selected covariates.

- Present the toxicity profiles of all patients.

- Measure serum levels of the pro-inflammatory cytokines IL-1, IL-6, TNF-α, the growth
factors TGF-α, EGF, NRG-1, VEGF, and triglycerides (TG) and correlate with fatigue and
other oncobehavioral 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.

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

- Arm II: Patients receive oral placebo twice daily on weeks 1-4. After week 4, all
patients receive oral L-carnitine twice daily on weeks 5-8.

Fatigue is assessed at baseline and then at weeks 4 and 8.

PROJECTED ACCRUAL: A total of 352 patients will be accrued for this study.

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 FACIT-F question "I feel fatigued"

- No brain metastases



- 18 and over

Performance status

- ECOG 0-3

Life expectancy

- Not specified


- Hemoglobin ≥ 9 g/dL


- No severe, uncontrolled liver disease


- No evidence of severely compromised renal function including any 1 of the following:

- Renal failure

- End stage renal disease

- Ongoing renal dialysis


- No severe, uncontrolled cardiovascular disease


- No severe, uncontrolled pulmonary disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

- No history of seizures

- No known sensitivity to carnitine

- No delirium

- No nausea > grade 1


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- Not specified


- Not specified


- More than 2 months since prior levocarnitine (L-carnitine) supplementation or
nutritional supplements containing carnitine

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Change in average daily fatigue as assessed by the Brief Fatigue Inventory (BFI) from baseline to 4 weeks

Safety Issue:


Principal Investigator

Ricardo Cruciani, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Medical Center - Petrie Division


United States: Federal Government

Study ID:




Start Date:

November 2005

Completion Date:

Related Keywords:

  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • fatigue
  • unspecified adult solid tumor, protocol specific
  • Fatigue



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