Breast Cancer, Reasoning, and Activity Intervention
Recruiting · NCT04816006 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Aerobic Exercise TrainingHealth Education (Active comparator)
What this trial is about
This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.
Who can take part
Age range
50 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and/or clinical determination
- PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and/or clinical determination
- PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-60 months prior to registration according to participant report and/or clinical determination
- PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months
- PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance
- REGISTRATION: Age ≥50 years as confirmed via clinical determination
- REGISTRATION: Able to provide medical record release to confirm eligibility
- REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer as confirmed via clinical determination
- REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-60 months prior to pre-registration as confirmed via clinical determination
- REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score \> 21) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy
- REGISTRATION: Receive physician's clearance to participate in an exercise program
- NOTE: Individuals with conditions/diagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:
- History of major multiple myocardial infarctions (MI)
- Recent electrocardiogram (ECG) changes or recent MI
- Resting or unstable angina
- Significant multivessel coronary occlusion (≥ 70%) on angiography
- Uncontrolled and/or serious arrhythmias
- 3rd degree heart block
- Acute congestive heart failure or ejection fraction \< 30%
- REGISTRATION: Ability to complete assessments by themselves or with assistance
Exclusion criteria
- PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease
- PRE-REGISTRATION: Currently receiving or \< 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 60 months post primary treatment
- PRE-REGISTRATION: Planned surgery during the intervention period
- PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)
- PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
- PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up
- PRE-REGISTRATION: Self-reported inability to walk without assistance or devices
- REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination
- REGISTRATION: Clinically significant TICS-M score (\< 21) during baseline procedures
- REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)
- REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols
- REGISTRATION: Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable/abnormal limited diagnostic brain image with recommended medical follow-up
- REGISTRATION: Enrolled in another physical activity program
- REGISTRATION: Unable to walk without assistance or devices
- REGISTRATION: Unwilling to complete study requirements
- REGISTRATION: Unwilling to be randomized to the exercise group or health education group
- REGISTRATION: Unable or unwilling to continuously wear and regularly sync/charge an activity tracker during the study period
- REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
- REGISTRATION: Unwilling to return to enrolling institution for follow-up
Where it is running
1 location listed across 1 US state.
- Mayo Clinic in Arizona - Phoenix, Arizona, United States