Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT00091169
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 \< 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00091169
Study Brief:
Protocol Section:
NCT00091169