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| Sponsors and Collaborators: |
Vanderbilt University Lance Armstrong Foundation |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00495703 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Chemotherapy Cognitive Impairment |
Behavioral: Exercise Behavioral: Usual Care |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Exercise Intervention for Chemotherapy-Related Cognitive Dysfunction |
| Enrollment: | 64 |
| Study Start Date: | February 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Exercise
|
Behavioral: Exercise
6-months of regular aerobic exercise
|
|
2: Active Comparator
Usual Care
|
Behavioral: Usual Care
6-months of behavioral strategies to aid memory/cognition
|
A substantial number of cancer survivors who receive chemotherapy report mild to moderate cognitive impairment following treatment. These impairments have been reported across a range of cancer types and chemotherapy agents. Adjuvant treatment has been reported to affect multiple cognitive domains, but three domains appear to be most strongly affected (i.e., executive functioning, declarative memory, motor function). Exercise participation, at levels that are readily achievable by most adults (3-5 d/wk, 30-45 min/d), preserves and enhances cognitive function. Importantly, domains that are enhanced by exercise overlap substantially with the domains adversely 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 (exercise, n=30 vs. standard of care, n=30); 2) explore possible mediators and moderators of the intervention effect on cognition; 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 will employ a proven home-based exercise intervention and state of the art cognitive testing of relevant cognitive domains (e.g., Randt Memory Test, Trail Making B, Stroop task, T ask switching, Response compatibility) that we have used in preliminary studies. 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. Completion of this project will provide our research team with the necessary experience and intervention effectiveness information that will be used to conduct future more definitive trials.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Non-metastatic cancer and received at least 4 cycles of chemotherapy, and report the onset of persistent cognitive difficulties following treatment Age 18+ yrs
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37203 | |
| Principal Investigator: | Charles E. Matthews, PhD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University ( Charles E. Matthews, PI ) |
| Study ID Numbers: | tactic |
| Study First Received: | July 2, 2007 |
| Last Updated: | April 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00495703 |
| Health Authority: | United States: Institutional Review Board |
|
Cancer survivors Chemotherapy Cognitive function Exercise Physical Activity |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Cognition Disorders Delirium |
