Exercise in Older Women With Breast Cancer During Systemic Therapy - a Randomized Controlled Trial (Breast Cancer Exercise Study)

Herlev and Gentofte Hospital1 site in 1 country68 target enrollmentNovember 15, 2018

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Herlev and Gentofte Hospital
Enrollment: 68
Locations: 1
Primary Endpoint: Change in the 30-second chair stand test
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

BREACE is a prospective randomized controlled trial. The aim is to investigate the effect of an exercise-based intervention among older participants with breast cancer treated with adjuvant or first-line systemic therapy.

The hypotheses: That the intervention will maintain or increase physical function levels, reduce symptoms and side effects, improve quality of life and psychological wellbeing, and prevent weight loss and muscle wasting

Registry

clinicaltrials.gov

Start Date

November 15, 2018

End Date

September 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Herlev and Gentofte Hospital

Responsible Party

Principal Investigator

Cecilia Margareta Lund

Herlev and Gentofte Hospital

Eligibility Criteria

Inclusion Criteria

•Participants must:
•Be operated for primary breast cancer within 12 weeks or
•Be diagnosed with locally advanced or metastatic breast cancer. Be treated with (neo)adjuvant or first or second-line palliative therapy defined as chemotherapy ± HER2 directed treatment, ± antihormonal treatment, antihormonal treatment ± HER 2, directed treatment ± CDK 4/6 inhibitor.
•Be ≥ 65 years of age at the time of signing the informed consent form
•Have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
•Be able to speak and read Danish, and to provide a signed informed consent form.

Exclusion Criteria

•Participants with:
•Any physical condition that hinder the execution of physical exercise training
•Other types of cancer
•Documented and uncontrolled brain metastases that hinder participation in an exercise-based trial, based on the referring oncologist's assessment
•Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder written consent
•Unstable medical disease or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted congestive heart failure (NYHA class III-IV), unstable angina pectoris, implantable cardioverter defibrillator (ICD), or myocardial infarction within 6 months, based on the referring oncologist's assessment.
•In patients with documented bone metastases:
•A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.

Outcomes

Primary Outcomes

Change in the 30-second chair stand test

Time Frame: baseline, 6 weeks, 12 weeks and 24 weeks

To measure change over time in the lower extremity strength, the number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest, is registered.

Secondary Outcomes

Body weight(baseline, 6 weeks, 12 weeks and 24 weeks)
The 6-meter Gait Speed Test(baseline, 6 weeks, 12 weeks and 24 weeks)
Adherence to exercise sessions(Up to 12 weeks)
Common Toxicity Criteria for Adverse Events version 4(up to 6 months)
The 6-minute-walk-test(baseline, 6 weeks, 12 weeks and 24 weeks)
Physical activity level(baseline and 12 weeks)
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30(baseline, 6 weeks, 12 weeks and 24 weeks)
The 10-meter Gait Speed Test(baseline, 6 weeks, 12 weeks and 24 weeks)
Stair climb test(baseline, 6 weeks, 12 weeks and 24 weeks)
Inflammation(Data will be recorded from the medical records)
Lengths of hospitalizations(up to 6 months)
whole-body lean body mass (LBM)(baseline and 12 weeks)
The Handgrip Strength Test(baseline, 6 weeks, 12 weeks and 24 weeks)
whole-body mineral density(baseline and 12 weeks)
Survival(up to 6 months)
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23(baseline, 6 weeks, 12 weeks and 24 weeks)
M.D. Anderson Symptom Inventory (MDASI)(baseline, 6 weeks, 12 weeks and 24 weeks)
Hospital Anxiety and Depression Scale (HADS)(baseline, 6 weeks, 12 weeks and 16 weeks)
Body mass index(baseline, 6 weeks, 12 weeks and 24 weeks)
whole-body fat mass(baseline and 12 weeks)
Adverse events(up to 12 weeks)
Number of hospitals admissions(up to 6 months)
Causes of hospitalizations(up to 6 months)