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NCT00091169 · ClinicalTrials.gov registry record · Phase 3
Levocarnitine in Treating Fatigue in Cancer Patients
A Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue, sponsored by ECOG-ACRIN Cancer Research Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 376
- Enrollment target
- 20
- Study locations
NCT00091169: Completed Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue, sponsored by ECOG-ACRIN Cancer Research Group.
NCT00091169 is a Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue that has completed, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 376 participants, below the 497-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00091169, a Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue, has completed, sponsored by ECOG-ACRIN Cancer Research Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 376 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.
Conditions Studied
Interventions
- OTHER placebo
- DIETARY_SUPPLEMENT levocarnitine
Study Locations (20)
Illinois
- Rush-Copley Cancer Care Center - Aurora
- St. Joseph Medical Center - Bloomington
- Graham Hospital - Canton
- Memorial Hospital - Carthage
- Eureka Community Hospital - Eureka
- Evanston Northwestern Healthcare - Evanston Hospital - Evanston
- Galesburg Clinic, PC - Galesburg
- Galesburg Cottage Hospital - Galesburg
- Mason District Hospital - Havana
- Hopedale Medical Complex - Hopedale
- Joliet Oncology-Hematology Associates, Limited - West - Joliet
- McDonough District Hospital - Macomb
- BroMenn Regional Medical Center - Normal
- Community Cancer Center - Normal
California
- Veterans Affairs Medical Center - Palo Alto - Palo Alto
- Stanford Comprehensive Cancer Center - Stanford - Stanford
Connecticut
- Praxair Cancer Center at Danbury Hospital - Danbury
- Manchester Memorial Hospital - Manchester
Florida
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center - Boca Raton
- Baptist Cancer Institute - Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2005-12-16 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00091169 record still lists
NCT00091169 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, below the 497-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (24% lower).
The record links to 2 conditions, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00091169 names 20 study sites across 4 states, led by Illinois, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00091169 about?
NCT00091169 is a clinical study titled "Levocarnitine in Treating Fatigue in Cancer Patients". 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.
What is the current status of trial NCT00091169?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 376 participants. The study started on 2005-12-16. Estimated completion is 2011-05.
What conditions does trial NCT00091169 study?
This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific, Fatigue.
What interventions are being tested in trial NCT00091169?
The interventions under investigation include: placebo (OTHER), levocarnitine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00091169?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00091169 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Unspecified Adult Solid Tumor, Protocol Specific
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00091169's enrollment target sits among peer trials
376 9th of 83 higher than 75 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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