Back to resultsExercise in Older Women With Breast Cancer During Systemic Therapy
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Breast cancer exercise intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring exercise, older, resistance training, breast cancer
Eligibility Criteria
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.
Sites / Locations
- Herlev and Gentofte HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group (n=50)
Control group (n=50)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The 6-meter Gait Speed Test
To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist.
The 10-meter Gait Speed Test
To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist
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
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
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.
Adherence to exercise sessions
Number of exercise sessions attended out of planned sessions
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.
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).
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".
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.
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.
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.
Body weight
Weight will be assessed using standard procedures (no shoes, light clothing) and will be reported in kilograms
Body mass index
Reported in kg/m^2
whole-body lean body mass (LBM)
Measured with bioimpedance and DXA scans
whole-body fat mass
Measured with bioimpedance and DXA scans
whole-body mineral density
Measured with bioimpedance and DXA scans
Inflammation
Inflammatory biomarkers: c-reactive protein, interleukin 6, YKL-40, GDF11 and GDF15.
Number of hospitals admissions
Data will be collected from medical records
Causes of hospitalizations
Data will be collected from medical records
Lengths of hospitalizations
Data will be collected from medical records
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.
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.
Full Information
NCT ID
NCT03656731
First Posted
August 22, 2018
Last Updated
September 29, 2023
Sponsor
Herlev and Gentofte Hospital
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT03656731
Brief Title
Exercise in Older Women With Breast Cancer During Systemic Therapy
Official Title
Exercise in Older Women With Breast Cancer During Systemic Therapy - a Randomized Controlled Trial (Breast Cancer Exercise Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
Collaborators
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
exercise, older, resistance training, breast cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 to the intervention group and control group
Masking
Outcomes Assessor
Masking Description
All physical tests will be conducted by masked health care professionals.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (n=50)
Arm Type
Experimental
Arm Description
Patients in the intervention group will receive standard care and a 12-week exercise-based intervention.
Arm Title
Control group (n=50)
Arm Type
No Intervention
Arm Description
Patient in the control group will receive standard care.
Intervention Type
Other
Intervention Name(s)
Breast cancer exercise intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in the 30-second chair stand test
Description
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 Outcome Measure Information:
Title
The 6-meter Gait Speed Test
Description
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
Title
The 10-meter Gait Speed Test
Description
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
Title
The 6-minute-walk-test
Description
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
Title
The Handgrip Strength Test
Description
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
Title
Stair climb test
Description
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
Title
Adherence to exercise sessions
Description
Number of exercise sessions attended out of planned sessions
Time Frame
Up to 12 weeks
Title
Physical activity level
Description
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
Title
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30
Description
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
Title
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23
Description
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
Title
M.D. Anderson Symptom Inventory (MDASI)
Description
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
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Common Toxicity Criteria for Adverse Events version 4
Description
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
Title
Body weight
Description
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
Title
Body mass index
Description
Reported in kg/m^2
Time Frame
baseline, 6 weeks, 12 weeks and 24 weeks
Title
whole-body lean body mass (LBM)
Description
Measured with bioimpedance and DXA scans
Time Frame
baseline and 12 weeks
Title
whole-body fat mass
Description
Measured with bioimpedance and DXA scans
Time Frame
baseline and 12 weeks
Title
whole-body mineral density
Description
Measured with bioimpedance and DXA scans
Time Frame
baseline and 12 weeks
Title
Inflammation
Description
Inflammatory biomarkers: c-reactive protein, interleukin 6, YKL-40, GDF11 and GDF15.
Time Frame
Data will be recorded from the medical records
Title
Number of hospitals admissions
Description
Data will be collected from medical records
Time Frame
up to 6 months
Title
Causes of hospitalizations
Description
Data will be collected from medical records
Time Frame
up to 6 months
Title
Lengths of hospitalizations
Description
Data will be collected from medical records
Time Frame
up to 6 months
Title
Survival
Description
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
Title
Adverse events
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Lund, MD, PhD
Phone
0045 38686112
Email
cecilia.margareta.lund.01@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Dorte Nielsen, Prof., DMSc
Email
dorte.nielsen.01@regionh.dk
Facility Information:
Facility Name
Herlev and Gentofte Hospital
City
Herlev
State/Province
Copenhagen
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Lund, MD, Phd.
Phone
0045 38686112
Email
cecilia.margareta.lund.01@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33033025
Citation
Andersen HH, Mikkelsen MK, Lundager I, Lund CM, Johansen JS, Vinther A, Bogh Juhl C, Zerahn B, Ragle AM, Nielsen DL. Exercise in older women with breast cancer during systemic therapy: study protocol of a randomised controlled trial (BREACE). BMJ Open. 2020 Oct 7;10(10):e038674. doi: 10.1136/bmjopen-2020-038674.
Results Reference
derived
Learn more about this trial
Exercise in Older Women With Breast Cancer During Systemic Therapy
We'll reach out to this number within 24 hrs