Exercise in Older Women With Breast Cancer During Systemic Therapy

Herlev and Gentofte Hospital68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Breast Cancer

Interventions

Breast cancer exercise interventionOTHER

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.

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Herlev and Gentofte Hospital

Herlev, Copenhagen, Denmark

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

The 6-meter Gait Speed Test

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

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

Data from ClinicalTrials.gov

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Adherence to exercise sessions

Number of exercise sessions attended out of planned sessions

Time frame: 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.

Time frame: 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).

Time frame: 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".

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: up to 6 months

Body weight

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

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

Body mass index

Reported in kg/m\^2

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

whole-body lean body mass (LBM)

Measured with bioimpedance and DXA scans

Time frame: baseline and 12 weeks

whole-body fat mass

Measured with bioimpedance and DXA scans

Time frame: baseline and 12 weeks

whole-body mineral density

Measured with bioimpedance and DXA scans

Time frame: baseline and 12 weeks

Inflammation

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

Time frame: Data will be recorded from the medical records

Number of hospitals admissions

Data will be collected from medical records

Time frame: up to 6 months

Causes of hospitalizations

Data will be collected from medical records

Time frame: up to 6 months

Lengths of hospitalizations

Data will be collected from medical records

Time frame: 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.

Time frame: 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.

Time frame: up to 12 weeks