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Aerobic Exercise and Cognitive Functioning in Women With Breast Cancer (ACTIVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277898
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : March 6, 2020
Sponsor:
Collaborators:
Canadian Cancer Society Research Institute (CCSRI)
Avon Foundation
University of Ottawa
BC Cancer Foundation (Vancouver/Surrey)
Information provided by (Responsible Party):
Kristin Campbell, University of British Columbia

Brief Summary:
In Canada, approximately 68 women are diagnosed with breast cancer every day. Chemotherapy-related cognitive changes (CRCC) are reported by up to 75% of breast cancer survivors during treatment and symptoms persist in 35% of survivors after treatment. Women report that CRCC negatively impacts their everyday functioning and substantially reduces their overall quality of life. Effective clinical interventions to manage CRCC are elusive. As a result, breast cancer survivors typically receive little to no advice on how to prevent or manage CRCC. Aerobic exercise is a type of physical activity that uses large muscle groups, is rhythmic in nature, and can be sustained for at least 10 minutes (e.g., walking, jogging, indoor cycling). It has been associated with improved quality of life in breast cancer survivors. It also holds great promise as an intervention to prevent or mitigate CRCC. However, there is limited evidence from experimental studies to confirm this. Therefore, the primary aim of this trial is to evaluate the impact of a supervised aerobic exercise intervention on CRCC in women diagnosed with early-stage breast cancer. Recruited women will be randomized into one of two groups: (1) aerobic exercise during chemotherapy, or (2) usual care during chemotherapy and the aerobic exercise post-chemotherapy (i.e., wait-list control group). This study will test several novel hypotheses, including whether exercise during chemotherapy can prevent and/or mitigate CRCC and its negative impact on quality of life among women with breast cancer, and whether the timing of the exercise intervention matters (i.e., exercise during versus after chemotherapy). The results of this study aim to address the concerns of women affected by CRCC who are currently lacking available evidence-based treatment options, as well as oncology care providers' need to have options to recommend to their patients to prevent or manage CRCC.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: Aerobic Exercise Behavioral: Usual Care (Wait-list Control) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aerobic Exercise and Cognitive Functioning in Women With Breast Cancer: the ACTIVATE Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise
Participants will complete three supervised aerobic exercise sessions each week using the treadmill, stationary bicycle or elliptical training for the duration of their chemotherapy (12-18 weeks). Aerobic exercise will be performed for 20-40 minutes at 50-75% of heart rate reserve. Participants will wear heart rate monitors during all supervised sessions (Polar Electro Inc., Lake Success, NY) and will be provided with target heart rates that will be individualized using their baseline (i.e., week 0) assessment data. Home-based exercise will be introduced in week 3. For the home-based sessions, participants will be asked to complete at least 1 session per week of 30 minutes of aerobic exercise (an activity of their choosing; e.g., walking).
Behavioral: Aerobic Exercise
Three weekly moderate-vigorous intensity supervised aerobic exercise training for the duration of adjuvant chemotherapy. Home-based exercise will also be introduced in week 3 of the intervention.

Usual Care (Wait-list Control)
Participants randomly assigned to UC group will be advised to continue with their regular activities of daily living. Following their chemotherapy, the UC group will receive the exercise intervention (lasting 12 weeks).
Behavioral: Usual Care (Wait-list Control)
Three weekly moderate-vigorous intensity supervised aerobic exercise training starting upon adjuvant chemotherapy completion. Home-based exercise will also be introduced in week 3 of the intervention.




Primary Outcome Measures :
  1. Change with treatment and maintenance post-treatment in objective neuropsychology test battery composite score [ Time Frame: Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline), 1-year follow-up (52 weeks post-baseline) ]
    A neuropsychological test battery. The tests are as follows: WAIS-IV (Digit-Symbol Coding, Letter-Number-Sequencing), Auditory Consonant Trigrams Test, Brief Visuospatial Memory Test Revised, Controlled Oral Word Association Test, Hopkins Verbal Learning Test-Revised, and Trail Making Test A&B. Alternate forms will be used, with the exception of the WAIS-IV tests, the Controlled Oral Word Association Test, and Trail Making A&B. These tests are combined to form a composite score called the COGSUM.


Secondary Outcome Measures :
  1. Change with treatment and maintenance post-treatment in self-reported cognitive function and impact on quality of life [ Time Frame: Pre-chemotherapy (baseline, week 0), mid-chemotherapy (week 6-9), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline), 1-year follow-up (52 weeks post-baseline). ]
    The Functional Assessment of Cancer Therapy (FACT)-Cognitive (Cog) Version 3

  2. Change with treatment and maintenance post-treatment in self-reported cognitive function [ Time Frame: Pre-chemotherapy (baseline, week 0), mid-chemotherapy (week 6-9), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline),1-year follow-up (52 weeks post-baseline). ]
    The Patient-Reported Outcomes Measurement Information System Applied Cognition short form

  3. Change with treatment and maintenance post-treatment in brain function and structure [ Time Frame: Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), 1-year follow-up (52 weeks post-baseline). ]
    Magnetic resonance imaging (MRI) assessment including a resting state fMRI procedure, a diffusion tensor imaging sequence, and three fMRI tasks (i.e., Letter N-Back and Word List Recognition Task).

  4. Change with treatment and maintenance post-treatment in electrical activity of the brain [ Time Frame: Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), 1-year follow-up (52 weeks post-baseline). ]
    Electroencephalogram (EEG) will be performed including five minutes of resting data and 20 minutes during a computerized task.


Other Outcome Measures:
  1. Change with treatment and maintenance post-treatment in aerobic fitness [ Time Frame: Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), follow-up (24-34 weeks post-baseline; UC participants only), 1-year follow-up (52 weeks post-baseline). ]
    Aerobic capacity (VO2peak) will be measured with a maximal cardiopulmonary test using a metabolic cart (PARVO Medics).

  2. Change with treatment and maintenance post-treatment in resting blood pressure [ Time Frame: Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), follow-up (24-34 weeks post-baseline; UC participants only), 1-year follow-up (52 weeks post-baseline). ]
    Resting blood pressure (mmHg), measured in duplicate on non-surgical side using a blood pressure monitor.

  3. Change with treatment and maintenance post-treatment in body composition [ Time Frame: Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), follow-up (24-34 weeks post-baseline; UC participants only), 1-year follow-up (52 weeks post-baseline). ]
    Height (using a stadiometer) and weight (using a standard scale)

  4. Socio-demographic information [ Time Frame: Pre-chemotherapy (baseline, week 0) ]
    Brief self-reported socio-demographic

  5. Medical characteristics [ Time Frame: Through study completion, an average of 1 year ]
    Measures will be extracted from participants' medical records at the Vancouver-BCCA and TOH (as appropriate). In particular, the following medical information will be extracted: cancer disease stage, treatment factors (i.e., type, timing, and dosage of all treatments including surgery/ies and adjuvant treatment(s)), and list of prescribed medications

  6. Change in exercise behaviour [ Time Frame: Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), follow-up and post-usual care wait-list control group receiving the intervention (24-34 weeks post-baseline), and 1-year follow-up (52 weeks) ]
    Modified version of the Leisure Time Exercise Questionnaire



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with stage I-III breast cancer;
  • Scheduled to receive adjuvant or neoadjuvant chemotherapy;
  • Able to speak and understand English in order to complete the study outcome measures;
  • Approval of medical oncologist to participate in the exercise intervention

Exclusion Criteria:

  • Having previously received chemotherapy or radiation therapy;
  • Score <24 at baseline on the Montreal Cognitive Assessment (MoCA; indicating moderate to severe cognitive impairment);
  • Having received a diagnosis of severe anxiety or mood disorder within the past year;
  • Having a medical condition that could impact cognition (e.g., prior head injury, substance use disorder);
  • Currently meeting American College of Sports Medicine (ACSM) aerobic exercise guidelines for cancer survivors in the 3 months prior to enrolment;
  • Body mass index ≥45 kg/m2;
  • Mobility issues that require a mobility aid or that prevent exercise on a bike, treadmill, or elliptical (e.g., orthopedic injury, severe arthritis).

Additional Inclusion/Exclusion Criteria: During the screening process, patients will be informed that they can participate in additional optional assessments (i.e., MRI and EEG (Vancouver site only for EEG)

Additional inclusion criteria for MRI:

  • Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during MRI tasks;
  • Able to read, understand, and provide informed consent in English for the additional assessments.

Additional exclusion criteria for MRI are:

  • Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning;
  • Claustrophobia;
  • Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner;
  • Lower back pain that would preclude a person from lying relatively still for one hour;
  • Breast tissue expander(s) inserted in the surgery site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277898


Contacts
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Contact: Aaliya Merali-Dewji, MSc 604-827-1914 aaliya.merali@ubc.ca

Locations
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Canada, British Columbia
Breast Cancer Training Center, 614 W. 8th Ave Recruiting
Vancouver, British Columbia, Canada, V5Z 1C8
Contact: Aaliya Merali-Dewji, MSc    604-872-4527    aaliya.merali@ubc.ca   
Clinical Exercise Physiology Lab Recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Aaliya Merali-Dewji, MSc    6048271914    aaliya.merali@ubc.ca   
Principal Investigator: Kristin L Campbell, BScPT, PhD         
Canada, Ontario
School of Human Kinetics - University of Ottawa Recruiting
Ottawa, Ontario, Canada
Contact: Jennifer Brunet, PhD       jennifer.brunet@uottawa.ca   
School of Human Kinetics - University of Ottawa Recruiting
Ottawa, Ontario, Canada
Contact: Meagan Barrett-Bernstein, MSc       meagan.barrett-bernstein@uottawa.ca   
Sponsors and Collaborators
University of British Columbia
Canadian Cancer Society Research Institute (CCSRI)
Avon Foundation
University of Ottawa
BC Cancer Foundation (Vancouver/Surrey)
Investigators
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Principal Investigator: Kristin L Campbell, PhD Department of Physical Therapy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristin Campbell, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03277898    
Other Study ID Numbers: H17-00563
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristin Campbell, University of British Columbia:
Breast Neoplasms
Exercise* OR "Aerobic Exercise"
Cognitive Function*
"Antineoplastic therapy" OR "Antineoplastic agent"
Chemotherapy, Adjuvant
Chemotherapy, Neoadjuvant
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases