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Completed

NCT Number: NCT03656731

Exercise in Older Women With Breast Cancer During Systemic Therapy

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

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Herlev and Gentofte Hospital

Herlev, Copenhagen, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast cancer exercise intervention

Other

The exercise-based intervention is comprised of:

  • 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.
  • Home-based walking with activity tracker assessment. Evaluation and goal-setting in relation to activity (step counts) will be conducted once weekly.
  • Serving of a protein supplement (protein drink or bar) after each supervised training session.

Primary outcomes

  1. 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

  1. The 6-meter Gait Speed Test

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

    To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist.

  2. The 10-meter Gait Speed Test

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

    To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist

  3. The 6-minute-walk-test

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

    To measure physical capacity and endurance. The distance (measured in meters) a participant is able to walk over a total of six minutes on a hard flat surface. The assessments will be conducted by a blinded physiotherapist

  4. The Handgrip Strength Test

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

    Physical function of the upper body will be measured using hand-held dynamometer. The assessment will be conducted by blinded physiotherapist

  5. Stair climb test

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

    To measure lower extremity muscle power. The patient will climb a flight of stairs (20 steps) as fast as possible. The assessment will be conducted by blinded physiotherapist.

  6. Adherence to exercise sessions

    Time frame: Up to 12 weeks

    Number of exercise sessions attended out of planned sessions

  7. Physical activity level

    Time frame: baseline and 12 weeks

    Data of step counts will be assessed daily for participants in the intervention group and will be measured with an activity tracker.

  8. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30

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

    Measure quality of life with the EORTC QLQ-C30 patient questionnaire. The questionnaire comprises 30 items, is designed to be cancer specific, and consists of six functional scales (physical, role, cognitive, emotional, social functioning, and global QOL) and symptom scales (fatigue, nausea/vomiting, sleep disturbance, constipation, diarrhea, appetite loss, dyspnea).

  9. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23

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

    Measure quality of life with the EORTC QLQ-BR23 patient questionnaire. The questionnaire is a breast cancer specific module to EORTC-QLQ-C30, comprises 23 items and consist of functional scales and symptom scales. Each item is scored on a scale from 1 to 4. 1 being "not at all" and 4 being "very much".

  10. M.D. Anderson Symptom Inventory (MDASI)

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

    The MDASI patient questionnaire measures the severity of symptoms and the interference with daily living asses by the participant based on the last 24 hours. The questionnaire consist of 13 core symptom items representing symptoms that have been found to have the highest frequency and/or severity among cancer patients with various cancers and treatment types, and 6 interference items representing commonly experienced symptom interference with daily activities.

  11. Hospital Anxiety and Depression Scale (HADS)

    Time frame: baseline, 6 weeks, 12 weeks and 16 weeks

    Measure symptoms of depression and anxiety with the HADS patient questionnaire. The questionnaire comprises a total of 14 items, generates ordinal data, and is designed to measure general anxiety and depression by self-administration. Seven of the items relate to anxiety and seven relate to depression. Each item is scored on a scale from 0 to 3 and this mean a participant can score between 0 and 21 for either anxiety and depression. Scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21.

  12. Common Toxicity Criteria for Adverse Events version 4

    Time frame: up to 6 months

    Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4. Data will be collected from medical records.

  13. Body weight

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

    Weight will be assessed using standard procedures (no shoes, light clothing) and will be reported in kilograms

  14. Body mass index

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

    Reported in kg/m^2

  15. whole-body lean body mass (LBM)

    Time frame: baseline and 12 weeks

    Measured with bioimpedance and DXA scans

  16. whole-body fat mass

    Time frame: baseline and 12 weeks

    Measured with bioimpedance and DXA scans

  17. whole-body mineral density

    Time frame: baseline and 12 weeks

    Measured with bioimpedance and DXA scans

  18. Inflammation

    Time frame: Data will be recorded from the medical records

    Inflammatory biomarkers: c-reactive protein, interleukin 6, YKL-40, GDF11 and GDF15.

  19. Number of hospitals admissions

    Time frame: up to 6 months

    Data will be collected from medical records

  20. Causes of hospitalizations

    Time frame: up to 6 months

    Data will be collected from medical records

  21. Lengths of hospitalizations

    Time frame: up to 6 months

    Data will be collected from medical records

  22. Survival

    Time frame: up to 6 months

    Incidences of deaths (cancer-related and other cause) will be registered. The purpose is to investigate whether the intervention may affect survival time/mortality. Data will be collected from medical records.

  23. Adverse events

    Time frame: up to 12 weeks

    Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Sep 4, 2018
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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