Exercise in Older Women With Breast Cancer During Systemic Therapy

Study Overview
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Brief Summary
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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

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Breast cancer exercise intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized 1:1 to the intervention group and control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (n=50)<br>Patients in the intervention group will receive standard care and a 12-week exercise-based intervention. | Other: Breast cancer exercise intervention<br>* 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.<br>|
| No Intervention: Control group (n=50)<br>Patient in the control group will receive standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 6-meter Gait Speed Test | To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist. | baseline, 6 weeks, 12 weeks and 24 weeks | 
| The 10-meter Gait Speed Test | To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist | baseline, 6 weeks, 12 weeks and 24 weeks | 
| The 6-minute-walk-test | 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 | baseline, 6 weeks, 12 weeks and 24 weeks | 
| The Handgrip Strength Test | Physical function of the upper body will be measured using hand-held dynamometer. The assessment will be conducted by blinded physiotherapist | baseline, 6 weeks, 12 weeks and 24 weeks | 
| Stair climb test | 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. | baseline, 6 weeks, 12 weeks and 24 weeks | 
| Adherence to exercise sessions | Number of exercise sessions attended out of planned sessions | Up to 12 weeks | 
| Physical activity level | Data of step counts will be assessed daily for participants in the intervention group and will be measured with an activity tracker. | baseline and 12 weeks | 
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 | 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). | baseline, 6 weeks, 12 weeks and 24 weeks | 
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23 | 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. | baseline, 6 weeks, 12 weeks and 24 weeks | 
| M.D. Anderson Symptom Inventory (MDASI) | 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. | baseline, 6 weeks, 12 weeks and 24 weeks | 
| Hospital Anxiety and Depression Scale (HADS) | 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. | baseline, 6 weeks, 12 weeks and 16 weeks | 
| Common Toxicity Criteria for Adverse Events version 4 | 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. | up to 6 months | 
| Body weight | Weight will be assessed using standard procedures (no shoes, light clothing) and will be reported in kilograms | baseline, 6 weeks, 12 weeks and 24 weeks | 
| Body mass index | Reported in kg/m^2 | baseline, 6 weeks, 12 weeks and 24 weeks | 
| whole-body lean body mass (LBM) | Measured with bioimpedance and DXA scans | baseline and 12 weeks | 
| whole-body fat mass | Measured with bioimpedance and DXA scans | baseline and 12 weeks | 
| whole-body mineral density | Measured with bioimpedance and DXA scans | baseline and 12 weeks | 
| Inflammation | Inflammatory biomarkers: c-reactive protein, interleukin 6, YKL-40, GDF11 and GDF15. | Data will be recorded from the medical records | 
| Number of hospitals admissions | Data will be collected from medical records | up to 6 months | 
| Causes of hospitalizations | Data will be collected from medical records | up to 6 months | 
| Lengths of hospitalizations | Data will be collected from medical records | up to 6 months | 
| Survival | 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. | up to 6 months | 
| Adverse events | Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events. | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, older, resistance training, breast cancer