Breast CancerNCT03656731
Exercise in Older Women With Breast Cancer During Systemic Therapy
A study testing Breast cancer exercise intervention in people with Breast Cancer, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast cancer exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2018to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise in Older Women With Breast Cancer During Systemic Therapy - a Randomized Controlled Trial (Breast Cancer Exercise Study)
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
- Conditions
- Breast Cancer
- Being tested
- Breast cancer exercise intervention
- Keywords
- exercise, older, resistance training, breast cancer
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast cancer exercise interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (n=50) | Experimental | Patients in the intervention group will receive standard care and a 12-week exercise-based intervention. Receives: Other: Breast cancer exercise intervention |
| Control group (n=50) | No intervention | Patient in the control group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks, 12 weeks and 24 weeks
Secondary outcomes (23)
The 6-meter Gait Speed Test
To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline, 6 weeks, 12 weeks and 24 weeks
Adherence to exercise sessions
Number of exercise sessions attended out of planned sessions
Measured: 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.
Measured: 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).
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 6 months
Body weight
Weight will be assessed using standard procedures (no shoes, light clothing) and will be reported in kilograms
Measured: baseline, 6 weeks, 12 weeks and 24 weeks
Body mass index
Reported in kg/m^2
Measured: baseline, 6 weeks, 12 weeks and 24 weeks
whole-body lean body mass (LBM)
Measured with bioimpedance and DXA scans
Measured: baseline and 12 weeks
whole-body fat mass
Measured with bioimpedance and DXA scans
Measured: baseline and 12 weeks
whole-body mineral density
Measured with bioimpedance and DXA scans
Measured: baseline and 12 weeks
Inflammation
Inflammatory biomarkers: c-reactive protein, interleukin 6, YKL-40, GDF11 and GDF15.
Measured: Data will be recorded from the medical records
Number of hospitals admissions
Data will be collected from medical records
Measured: up to 6 months
Causes of hospitalizations
Data will be collected from medical records
Measured: up to 6 months
Lengths of hospitalizations
Data will be collected from medical records
Measured: 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.
Measured: 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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start15 Nov 2018
- Primary completion31 Dec 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to the intervention group and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Cecilia Margareta Lund, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656731
- Sponsor's protocol ID
- BREACE
- Status last verified
- Oct 2024
- First submitted
- 22 Aug 2018
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33033025
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Older Women With Breast Cancer During Systemic Therapy - a Randomized Controlled Trial (Breast Cancer Exercise Study)
- ClinicalTrials.gov ID
- NCT03656731
- Acronym / sponsor ID
- BREACE
- Conditions
- Breast Cancer
- Keywords
- exercise, older, resistance training, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to the intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group (n=50) | Experimental | Other: Breast cancer exercise interventionPatients in the intervention group will receive standard care and a 12-week exercise-based intervention. |
| Control group (n=50) | No intervention | –Patient in the control group will receive standard care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast cancer exercise interventionThe 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. | Other | Intervention group (n=50) |
Primary outcome
Change in the 30-second chair stand test
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
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.
23 secondary outcomes
The 6-meter Gait Speed Test
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
The 10-meter Gait Speed Test
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
The 6-minute-walk-test
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
The Handgrip Strength Test
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
Stair climb test
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
Adherence to exercise sessions
Time frame: Up to 12 weeks
Physical activity level
Time frame: baseline and 12 weeks
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
M.D. Anderson Symptom Inventory (MDASI)
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline, 6 weeks, 12 weeks and 16 weeks
Common Toxicity Criteria for Adverse Events version 4
Time frame: up to 6 months
Body weight
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
Body mass index
Time frame: baseline, 6 weeks, 12 weeks and 24 weeks
whole-body lean body mass (LBM)
Time frame: baseline and 12 weeks
whole-body fat mass
Time frame: baseline and 12 weeks
whole-body mineral density
Time frame: baseline and 12 weeks
Inflammation
Time frame: Data will be recorded from the medical records
Number of hospitals admissions
Time frame: up to 6 months
Causes of hospitalizations
Time frame: up to 6 months
Lengths of hospitalizations
Time frame: up to 6 months
Survival
Time frame: up to 6 months
Adverse events
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Derived from this study: PubMed 33033025Andersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast cancer exercise intervention in people with Breast Cancer, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 30-second chair stand test (time frame: baseline, 6 weeks, 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.