Phase 3 N=376 Randomized Triple-blind Supportive Care

Levocarnitine in Treating Fatigue in Cancer Patients

Fatigue · Unspecified Adult Solid Tumor, Protocol Specific

Bottom Line

View on ClinicalTrials.gov: NCT00091169 ↗

Enrolled (actual)

376

Serious AEs

4.8%

Results posted

May 2016

Primary outcome: Primary: Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks — -0.96; -1.11 units on a scale — p=0.57

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: levocarnitine (Dietary_supplement); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ECOG-ACRIN Cancer Research Group
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks	-0.96; -1.11	0.57
SECONDARY Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks	5.36; 4.04	0.64
SECONDARY Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline	-3.05; -2.91	0.93
SECONDARY Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks	-0.19; -0.08	0.61
SECONDARY Prevalence of Carnitine Deficiency at 4 Weeks	0.113; 0.333	0.00001 sig
SECONDARY Proportion of Patients With Stable or Improving Performance Status at 4 Weeks	0.806; 0.875	0.677

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.

Eligibility Criteria

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 grade 1
Taking any form of levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine within 2 months prior to registration

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00091169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.