Exercise in Older Women With Breast Cancer During Systemic Therapy

Herlev and Gentofte Hospital

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Breast cancer exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03656731

BREACE

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Intervention group (n=50)

Experimental group

Description:

Patients in the intervention group will receive standard care and a 12-week exercise-based intervention.

Treatment:

Other: Breast cancer exercise intervention

Control group (n=50)

No Intervention group

Description:

Patient in the control group will receive standard care.