Exercise in Older Women With Breast Cancer During Systemic Therapy

NCT03656731 | Completed DMC

• 1 other identifier: BREACE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

exercise; older; resistance training; breast cancer

Outcome Measures

Primary Outcomes (1)

• Change in the 30-second chair stand test

  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.

  baseline, 6 weeks, 12 weeks and 24 weeks

Secondary Outcomes (23)

• The 6-meter Gait Speed Test

  baseline, 6 weeks, 12 weeks and 24 weeks

• The 10-meter Gait Speed Test

  baseline, 6 weeks, 12 weeks and 24 weeks

• The 6-minute-walk-test

  baseline, 6 weeks, 12 weeks and 24 weeks

• The Handgrip Strength Test

  baseline, 6 weeks, 12 weeks and 24 weeks

• Stair climb test

  baseline, 6 weeks, 12 weeks and 24 weeks

Study Arms (2)

Intervention group (n=50)

EXPERIMENTAL

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

Other: Breast cancer exercise intervention

Control group (n=50)

NO INTERVENTION

Patient in the control group will receive standard care.

Interventions

Breast cancer exercise intervention OTHER

The exercise-based intervention is comprised of: 1. Supervised and group-based exercise training at the hospital setting two times a week. Each session will last approximately 60 minutes.The program consists of warm-up, exercises for balance and flexibility, progressive resistance training (seven resistance training exercises targeting the large muscle groups), and stretching and relaxation. 2. Home-based walking with activity tracker assessment. Evaluation and goal-setting in relation to activity (step counts) will be conducted once weekly. 3. Serving of a protein supplement (protein drink or bar) after each supervised training session.

Intervention group (n=50)

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, Copenhagen, 2730, Denmark

Location

Related Publications (1)

• Andersen HH, Mikkelsen MK, Lundager I, Lund CM, Johansen JS, Vinther A, Bogh Juhl C, Zerahn B, Ragle AM, Nielsen DL. Exercise in older women with breast cancer during systemic therapy: study protocol of a randomised controlled trial (BREACE). BMJ Open. 2020 Oct 7;10(10):e038674. doi: 10.1136/bmjopen-2020-038674.

  PMID: 33033025 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All physical tests will be conducted by masked health care professionals.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be randomized 1:1 to the intervention group and control group

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 4, 2018
• Study Start: November 15, 2018
• Primary Completion: December 31, 2023
• Study Completion: September 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)