The Activity Intervention for Chemobrain

NCT00495703 | Completed Phase 2

• 1 other identifier: tactic
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Chemotherapy; Cognitive Impairment

Keywords

Cancer survivors; Chemotherapy; Cognitive function; Exercise; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Objective measures of cognitive function (a test battery)

  6-months

Secondary Outcomes (1)

• Exploratory analyses of psychological status, cardiorespiratory fitness, and inflammatory markers in blood.

  6-months

Study Arms (2)

1

EXPERIMENTAL

Exercise

Behavioral: Exercise

2

ACTIVE COMPARATOR

Usual Care

Behavioral: Usual Care

Interventions

Exercise BEHAVIORAL

6-months of regular aerobic exercise

1

Usual Care BEHAVIORAL

6-months of behavioral strategies to aid memory/cognition

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Non-metastatic cancer and received at least 4 cycles of chemotherapy, and report the onset of persistent cognitive difficulties following treatment Age 18+ yrs

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Lance Armstrong Foundation: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Charles E. Matthews, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 3, 2007
• Study Start: February 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)