Recruiting

Aerobic Exercise

Sponsor:

University of British Columbia

Code:

NCT03277898

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: Female

Age: 19 - 70

Healthy Volunteers: Not accepted

Interventions

Aerobic Exercise

Usual Care (Wait-list Control)

Study Details

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

Study ID

NCT03277898

Start date

Nov 1, 2017

Status verified date

Feb, 2021

Completion date

Jan 1, 2022

Anticipated

Primary completion date

May 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

other: 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).

Interventions

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)

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Aaliya Merali-Dewji, MSc

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

Locations

Breast Cancer Training Center, 614 W. 8th Ave

Recruiting

Vancouver, British Columbia, Canada, V5Z 1C8

Contacts

Aaliya Merali-Dewji, MSc

604-872-4527aaliya.merali@ubc.ca

Clinical Exercise Physiology Lab

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

Contacts

Aaliya Merali-Dewji, MSc

6048271914aaliya.merali@ubc.ca

Principal Investigator:

Kristin L Campbell, BScPT, PhD

School of Human Kinetics - University of Ottawa

Recruiting

Ottawa, Ontario, Canada

Contacts

Nicole Giouridis

ngiourid@uottawa.ca

School of Human Kinetics - University of Ottawa

Recruiting

Ottawa, Ontario, Canada

Contacts

Jennifer Brunet, PhD

jennifer.brunet@uottawa.ca

More Information

Sponsor

University of British Columbia

Last update posted

Feb 11, 2021

Last verified

Feb, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2021-02-11.