Exercise intervention to improve cognitive function in breast cancer survivors

Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training

This study tests whether a 6-month aerobic exercise program can help improve memory and attention in post-menopausal breast cancer survivors compared to those who only receive health education.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 50 Years and up
• Sex: Female
• Sponsor: Mayo Clinic (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Phoenix, Arizona)
• Trial ID: NCT04816006 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of a 6-month aerobic exercise program aimed at enhancing cognitive function in post-menopausal breast cancer survivors. Participants are randomized into two groups: one receiving supervised exercise sessions and the other receiving health education materials. The study evaluates cognitive outcomes such as memory and attention, while also exploring the scalability of the intervention using the RE-AIM framework. Additionally, it examines potential biomarkers related to diet patterns through urinary metabolites.

Who should consider this trial

Good fit: Ideal candidates are post-menopausal women aged 18 and older who have completed primary treatment for stage I-IIIa breast cancer and are currently sedentary.

Not a fit: Patients who are not post-menopausal or those who have not completed their primary cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve cognitive function and quality of life for breast cancer survivors.

How similar studies have performed: Other studies have shown promising results with exercise interventions improving cognitive function in cancer survivors, indicating a potential for success in this approach.

Eligibility criteria

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) 3-36 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) 3-36 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 36 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 this trial is running

Phoenix, Arizona

• Mayo Clinic in Arizona — Phoenix, Arizona, United States (RECRUITING)

Study contacts

• Principal investigator: Diane K. Ehlers, Ph.D. — Mayo Clinic
• Study coordinator: Melissa Cole, MS

Conditions: Breast Cancer, Breast Neoplasms, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Cancer-related Cognitive Dysfunction, physical activity, exercise