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NCT00495703 · ClinicalTrials.gov registry record · Phase 2
The Activity Intervention for Chemobrain
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT00495703 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 64 participants.
The verdict
NCT00495703, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Cognitive dysfunction following chemotherapy is an adverse treatment effect that impacts the quality of life for many cancer survivors receiving this adjuvant therapy. A strong body of evidence now indicates that that the initiation of a regular exercise program, at levels that are readily achievable by most adults (3-5 d/wk, 30-45 min/session), can improve cognitive function. Importantly, the domains of cognitive function that are enhanced by exercise participation are the same domains that are negatively affected by chemotherapy. Accordingly, we propose a 2 year research program that seeks to develop and test a safe, simple, and effective exercise intervention to optimize cognitive function following chemotherapy. To begin this research, we will: 1) conduct a randomized exercise intervention trial among cancer survivors that report persistent cognitive problems following chemotherapy (n=60), 2) explore possible mediators and moderators of the intervention on cognition in order to begin to understand how the intervention may work and for whom it may be most effective, and 3), conduct a cross-sectional study comparing cancer survivors enrolled in the trial (n=60) and matched controls (n=40) to evaluate the cognitive status among survivors in the intervention. We hypothesize that six-months of regular exercise will enhance cognitive function among cancer survivors, and that cancer survivors reporting cognitive dysfunction will have lower objectively measured cognitive performance than adults who have not received chemotherapy. To our knowledge this study would be the first to examine the influence of regular exercise participation on cognitive function among cancer survivors that experienced cognitive difficulties following chemotherapy.
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00495703
The ClinicalTrials.gov registry entry for NCT00495703 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT00495703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00495703 about?
NCT00495703 is a clinical study titled "The Activity Intervention for Chemobrain". Cognitive dysfunction following chemotherapy is an adverse treatment effect that impacts the quality of life for many cancer survivors receiving this adjuvant therapy. A strong body of evidence now indicates that that the initiation of a regular exercise program, at levels that are readily achievabl...
What is the current status of trial NCT00495703?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2006-02. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00495703?
The interventions under investigation include: Usual Care (BEHAVIORAL), Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT00495703?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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