The Activity Intervention for Chemobrain (TACTIC)

This study has been completed.
Sponsor:
Collaborator:
Lance Armstrong Foundation
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00495703
First received: July 2, 2007
Last updated: April 4, 2008
Last verified: April 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Exercise Intervention for Chemotherapy-Related Cognitive Dysfunction

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Objective measures of cognitive function (a test battery) [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Exploratory analyses of psychological status, cardiorespiratory fitness, and inflammatory markers in blood. [ Time Frame: 6-months ] [ Designated as safety issue: No ]

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
Experimental: 1
Exercise
Behavioral: Exercise
6-months of regular aerobic exercise
Active Comparator: 2
Usual Care
Behavioral: Usual Care
6-months of behavioral strategies to aid memory/cognition

Detailed Description:

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
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495703

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
Lance Armstrong Foundation
Investigators
Principal Investigator: Charles E. Matthews, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Charles E. Matthews, PI, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00495703     History of Changes
Other Study ID Numbers: tactic
Study First Received: July 2, 2007
Last Updated: April 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Cancer survivors
Chemotherapy
Cognitive function
Exercise
Physical Activity

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014