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NCT00376675 · ClinicalTrials.gov registry record · Phase 3
Methylphenidate in Treating Patients With Fatigue Caused by Cancer
A Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
- 20
- Study locations
NCT00376675: Completed Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue, sponsored by Alliance for Clinical Trials in Oncology.
NCT00376675 is a Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 148 participants, below the 499-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00376675, a Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Fatigue, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 148 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known whether methylphenidate is more effective than a placebo in relieving fatigue and improving quality of life in patients with cancer. PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works in treating patients with fatigue caused by cancer.
Primary Outcome
The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following: 1. For those completed 4 weeks item: AUC/4; 2. For those completed up to week 3 item: (AUC \* 4) / 3; 3. For those completed up to week 2 item: AUC \* 2; 4. For those completed up to week 1 item: AUC \* 4; The prorated AUC scores we
Conditions Studied
Interventions
- OTHER placebo
- DRUG methylphenidate hydrochloride
Study Locations (20)
Colorado
- Aurora Presbyterian Hospital - Aurora
- Boulder Community Hospital - Boulder
- Penrose Cancer Center at Penrose Hospital - Colorado Springs
- St. Anthony Central Hospital - Denver
- Porter Adventist Hospital - Denver
- Presbyterian - St. Luke's Medical Center - Denver
- St. Joseph Hospital - Denver
- Rose Medical Center - Denver
- CCOP - Colorado Cancer Research Program - Denver
- Swedish Medical Center - Englewood
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center - Grand Junction
- North Colorado Medical Center - Greeley
- Sky Ridge Medical Center - Lone Tree
- Hope Cancer Care Center at Longmont United Hospital - Longmont
- McKee Medical Center - Loveland
- St. Mary - Corwin Regional Medical Center - Pueblo
- North Suburban Medical Center - Thornton
- Exempla Lutheran Medical Center - Wheat Ridge
Arizona
- Mayo Clinic Scottsdale - Scottsdale
Florida
- Mayo Clinic - Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00376675 record still lists
NCT00376675 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 499-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (70% 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.
NCT00376675 names 20 study sites across 3 states, led by Colorado, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT00376675 about?
NCT00376675 is a clinical study titled "Methylphenidate in Treating Patients With Fatigue Caused by Cancer". RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known whether methylphenidate is more effective than a placebo in relieving fatigue and improving quality of life in patients with cancer. PURPOSE: This randomized phase III trial is studying methylphenidate to see ...
What is the current status of trial NCT00376675?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2008-02. Estimated completion is 2010-06.
What conditions does trial NCT00376675 study?
This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific, Fatigue.
What interventions are being tested in trial NCT00376675?
The interventions under investigation include: placebo (OTHER), methylphenidate hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00376675?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00376675 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida. 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 NCT00376675's enrollment target sits among peer trials
148 14th of 83 higher than 70 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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