Clinical trial · Interventional
Levocarnitine in Treating Fatigue in Cancer Patients
Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer
NCT00091169CI-TRIAL-00067790completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| levocarnitine | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.
- interventionNames
- Dietary Supplement: levocarnitine
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo twice daily on weeks 1-4.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks
- timeFrame
- assessed at baseline and 4 weeks after randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTCruciani RA, Zhang JJ, Manola J, Cella D, Ansari B, Fisch MJ. 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. J Clin Oncol. 2012 Nov 1;30(31):3864-9. doi: 10.1200/JCO.2011.40.2180. Epub 2012 Sep 17. PMID 22987089
- RESULTRich TA, Manola J, Cella D, et al.: An evaluation of serum cytokine levels and fatigue and depression in ECOG E4Z02. [Abstract] J Clin Oncol 29 (Suppl 15): A-9046, 2011.
- RESULTRich TA, Fisch MJ, Manola J, et al.: Analysis of cytokines in ECOG E4Z02: A phase III randomized study of l-carnitine supplementation for fatigue in patients with cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-9635, 2009.