Aerobic Exercise and Cognitive Functioning in Women With Breast Cancer

NCT03277898 | Unknown DMC

• 1 other identifier: H17-00563
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Neoplasms

Keywords

Breast Neoplasms; Exercise* OR "Aerobic Exercise"; Cognitive Function*; "Antineoplastic therapy" OR "Antineoplastic agent"; Chemotherapy, Adjuvant; Chemotherapy, Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Change with treatment and maintenance post-treatment in objective neuropsychology test battery composite score

  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.

  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)

Secondary Outcomes (4)

• Change with treatment and maintenance post-treatment in self-reported cognitive function and impact on quality of life

  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).

• Change with treatment and maintenance post-treatment in self-reported cognitive function

  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).

• Change with treatment and maintenance post-treatment in brain function and structure

  Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), 1-year follow-up (52 weeks post-baseline).

• Change with treatment and maintenance post-treatment in electrical activity of the brain

  Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), 1-year follow-up (52 weeks post-baseline).

Other Outcomes (6)

• Change with treatment and maintenance post-treatment in aerobic fitness

  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).

• Change with treatment and maintenance post-treatment in resting blood pressure

  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).

• Change with treatment and maintenance post-treatment in body composition

  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).

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

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

Usual Care (Wait-list Control)

OTHER

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)

Interventions

Aerobic Exercise BEHAVIORAL

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.

Aerobic Exercise

Usual Care (Wait-list Control) BEHAVIORAL

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.

Usual Care (Wait-list Control)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Cancer Society (CCS): collaborator
• Avon Foundation: collaborator
• University of Ottawa: collaborator
• British Columbia Cancer Agency: collaborator

Study Sites (4)

Breast Cancer Training Center, 614 W. 8th Ave

Vancouver, British Columbia, V5Z 1C8, Canada

RECRUITING

Clinical Exercise Physiology Lab

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

School of Human Kinetics - University of Ottawa

Ottawa, Ontario, Canada

RECRUITING

School of Human Kinetics - University of Ottawa

Ottawa, Ontario, Canada

RECRUITING

Related Publications (2)

• Damji S, Sattari S, Zadravec K, Campbell KL, Brunet J, Virji-Babul N. Changes in EEG Microstate Dynamics and Cognition Post-Chemotherapy in People With Breast Cancer. Brain Behav. 2025 Mar;15(3):e70335. doi: 10.1002/brb3.70335.

  PMID: 40038798 DERIVED

• Brunet J, Barrett-Bernstein M, Zadravec K, Taljaard M, LeVasseur N, Srikanthan A, Bland KA, Collins B, Kam JWY, Handy TC, Hayden S, Simmons C, Smith AM, Virji-Babul N, Campbell KL. Study protocol of the Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial: a two-arm, two-centre randomized controlled trial. BMC Cancer. 2020 Jul 31;20(1):711. doi: 10.1186/s12885-020-07196-3.

  PMID: 32736542 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kristin L Campbell, PhD

  Department of Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaliya Merali-Dewji, MSc

CONTACT

604-827-1914; aaliya.merali@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: September 11, 2017
• Study Start: November 1, 2017
• Primary Completion: May 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

CA (4)