Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

Patient in the control group will receive standard care.

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.

Breast cancer exercise intervention

Cecilia Lund, MD, PhD

Dorte Nielsen, Prof., DMSc

Cecilia Lund, MD, Phd.

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

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

All physical tests will be conducted by masked health care professionals.

Exercise in Older Women With Breast Cancer During Systemic Therapy

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

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.

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

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

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

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

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.

Number of exercise sessions attended out of planned sessions

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

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).

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".

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.

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.

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.

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

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

Data will be collected from medical records

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.

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

Spots Global Cancer Trial Database for breast cancer exercise intervention