Exercise in Older Women With Breast Cancer During Systemic Therapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03656731
• Other study ID #: BREACE
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Herlev and Gentofte Hospital
• Contact: Cecilia Lund, MD, PhD
• Phone: 0045 38686112
• Email: cecilia.margareta.lund.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Breast cancer exercise intervention
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.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Herlev	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence to exercise sessions	Number of exercise sessions attended out of planned sessions	Up to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Body mass index	Reported in kg/m^2	baseline, 6 weeks, 12 weeks and 24 weeks
Secondary	whole-body lean body mass (LBM)	Measured with bioimpedance and DXA scans	baseline and 12 weeks
Secondary	whole-body fat mass	Measured with bioimpedance and DXA scans	baseline and 12 weeks
Secondary	whole-body mineral density	Measured with bioimpedance and DXA scans	baseline and 12 weeks
Secondary	Inflammation	Inflammatory biomarkers: c-reactive protein, interleukin 6, YKL-40, GDF11 and GDF15.	Data will be recorded from the medical records
Secondary	Number of hospitals admissions	Data will be collected from medical records	up to 6 months
Secondary	Causes of hospitalizations	Data will be collected from medical records	up to 6 months
Secondary	Lengths of hospitalizations	Data will be collected from medical records	up to 6 months
Secondary	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
Secondary	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