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Exercise Intervention for Chemotherapy-Related Cognitive Dysfunction


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer, Chemotherapy, Cognitive Impairment

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Trial Information

Exercise Intervention for Chemotherapy-Related Cognitive Dysfunction


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.


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:

1. Have no prior diagnosis of cancer of the central nervous system,

2. Not have engaged in regular exercise in the past year (i.e., 5+ days/wk, 20+ min/d,
3+ months),

3. No cardiovascular disease or orthopedic problems that could be worsened by exercise
as reported on the Physical Activity Readiness Questionnaire

4. No major systemic diseases (e.g., liver, kidney or adrenal diseases).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Objective measures of cognitive function (a test battery)

Outcome Time Frame:

6-months

Safety Issue:

Yes

Principal Investigator

Charles E. Matthews, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University

Authority:

United States: Institutional Review Board

Study ID:

tactic

NCT ID:

NCT00495703

Start Date:

February 2006

Completion Date:

January 2008

Related Keywords:

  • Cancer
  • Chemotherapy
  • Cognitive Impairment
  • Cancer survivors
  • Chemotherapy
  • Cognitive function
  • Exercise
  • Physical Activity
  • Cognition Disorders

Name

Location

Vanderbilt University Medical Center Nashville, Tennessee  37232-2516