The Activity Intervention for Chemobrain - Full Text View

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 Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Supportive Care
Official Title:	Exercise Intervention for Chemotherapy-Related Cognitive Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:

Objective measures of cognitive function (a test battery) [ Time Frame: 6-months ]

Secondary Outcome Measures:

Exploratory analyses of psychological status, cardiorespiratory fitness, and inflammatory markers in blood. [ Time Frame: 6-months ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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:

Have no prior diagnosis of cancer of the central nervous system,
Not have engaged in regular exercise in the past year (i.e., 5+ days/wk, 20+ min/d, 3+ months),
No cardiovascular disease or orthopedic problems that could be worsened by exercise as reported on the Physical Activity Readiness Questionnaire
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 Medical Center

Lance Armstrong Foundation

Investigators


Principal Investigator:	Charles E. Matthews, PhD	Vanderbilt University Medical Center

More Information


Responsible Party:	Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:	NCT00495703 History of Changes
Other Study ID Numbers:	tactic
Study First Received:	July 2, 2007
Last Updated:	March 30, 2017

Keywords provided by Vanderbilt University Medical Center:


Cancer survivors Chemotherapy Cognitive function Exercise Physical Activity

Additional relevant MeSH terms:


Cognition Disorders Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on July 17, 2017

The Activity Intervention for Chemobrain (TACTIC)