Phase 3
Completed N=376
Levocarnitine in Treating Fatigue in Cancer Patients
Fatigue · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00091169 ↗
Enrolled (actual)
376
Serious AEs
4.8%
Results posted
May 2016
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
▲ Trending
100citations · ~7 / year
L-carnitine supplementation for the management of fatigue in patients with cancer: an eastern cooperative oncology group phase III, randomized, double-blind, placebo-controlled trial.
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.
Linked Publications
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L-carnitine supplementation for the management of fatigue in patients with cancer: an eastern cooperative oncology group phase III, randomized, double-blind, placebo-controlled trial.
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 |
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
Data sourced from ClinicalTrials.gov (NCT00091169) and the linked publication. 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. Informational only — not medical advice.