Clinical trial NCT03656731: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: exercise
older
resistance training
breast cancer
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2018-09-04
Enrollment: 68
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to the intervention group and control group
Primary purpose: SUPPORTIVE_CARE

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


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.

Primary outcomes:
measure: Change in the 30-second chair stand test
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
Secondary outcomes:
measure: The 6-meter Gait Speed Test
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: The 10-meter Gait Speed Test
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: The 6-minute-walk-test
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: The Handgrip Strength Test
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: Stair climb test
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: Adherence to exercise sessions
timeFrame: Up to 12 weeks
measure: Physical activity level
timeFrame: baseline and 12 weeks
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: M.D. Anderson Symptom Inventory (MDASI)
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, 6 weeks, 12 weeks and 16 weeks
measure: Common Toxicity Criteria for Adverse Events version 4
timeFrame: up to 6 months
measure: Body weight
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: Body mass index
timeFrame: baseline, 6 weeks, 12 weeks and 24 weeks
measure: whole-body lean body mass (LBM)
timeFrame: baseline and 12 weeks
measure: whole-body fat mass
timeFrame: baseline and 12 weeks
measure: whole-body mineral density
timeFrame: baseline and 12 weeks
measure: Inflammation
timeFrame: Data will be recorded from the medical records
measure: Number of hospitals admissions
timeFrame: up to 6 months
measure: Causes of hospitalizations
timeFrame: up to 6 months
measure: Lengths of hospitalizations
timeFrame: up to 6 months
measure: Survival
timeFrame: up to 6 months
measure: Adverse events
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
state: Copenhagen
Study officials:
References:
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.