Aerobic Exercise and Cognitive Functioning in Women With Breast Cancer

NCT03277898 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-02-11

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER
  • Avon Foundation

    collaborator OTHER
  • University of Ottawa

    collaborator OTHER
  • British Columbia Cancer Agency

    collaborator OTHER
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Kristin L Campbell, PhD · Department of Physical Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-05-01
Completion
2022-01-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03277898 on ClinicalTrials.gov