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Exercise for Breast Cancer Cognitive Function (BRAIN Trial)

N/A

Recruiting

Led By Diane K. Ehlers, Ph.D.

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

First, primary diagnosis of Stage I-IIIa breast cancer

Post-menopausal at diagnosis (no menses for 12 mo.)

Must not have

Unwilling to complete study requirements

Unable to travel regularly to the study locations for intervention sessions and data collection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (month 0), post-intervention (month 6), follow up (month 12)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if exercise can improve cognitive function in post-menopause breast cancer survivors.

Who is the study for?

This trial is for post-menopausal women who had a first, primary diagnosis of Stage I-IIIa breast cancer, are sedentary, and have completed their main treatments between 3-24 months ago. They must be cleared by a physician to exercise and agree to randomization. Excluded are those with second cancer diagnoses (except certain skin cancers), significant cognitive impairment, recent or ongoing chemotherapy or radiation therapy, neurological disorders, planned surgeries during the study period, or contraindications to MRI.

What is being tested?

The study aims to see if aerobic exercise training improves cognitive function in these survivors compared to health education. Participants will either join an exercise program or receive health education as an active comparator. The effectiveness of the interventions will be measured through changes in cognitive function.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects from participating could include typical risks associated with starting an exercise regimen such as muscle soreness, fatigue, and increased risk of injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My first cancer diagnosis is Stage I-IIIa breast cancer.

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I have been post-menopausal since my diagnosis.

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I was post-menopausal when my cancer was diagnosed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing to follow all study requirements.

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I cannot travel often to the study site for treatments and tests.

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I have had a stroke, TIA, brain surgery, or other neurological disorders.

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I have been diagnosed with a second cancer, not including non-invasive skin cancers.

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I am unwilling or unable to return to the hospital where I was enrolled for follow-up visits.

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I was pre- or peri-menopausal when diagnosed with breast cancer.

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I cannot or do not want to use an activity tracker regularly during the study.

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I am scheduled for surgery during the study period.

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I am not willing to be assigned randomly to an exercise or health education group.

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My breast cancer is either very early stage or has spread to other parts of my body.

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I need help or devices to walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (month 0), post-intervention (month 6), follow up (month 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (month 0), post-intervention (month 6), follow up (month 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (month 0), post-intervention (month 6), follow up (month 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adoption

Change in Cancer-related Fatigue

Change in Cardiorespiratory Fitness

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (Aerobic Exercise)Experimental Treatment1 Intervention

Patients attend 3 weekly exercise sessions in weeks 1-2, 2 sessions each week in weeks 3-4, 1 session each week in weeks 5-8, biweekly sessions across weeks 9-16, and monthly sessions in weeks 17-24 for a total of 20 supervised sessions. Patients undergo a gait assessment and magnetic resonance imaging (MRI), as well as wear an accelerometer throughout the study.

Group II: Arm II (Health Education)Active Control1 Intervention

Patients participate in up to 9 monthly classes/webinars. Patients also receive informational pdfs, videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Exercise Training

2020

Completed Phase 4

~5450

0 / 14Eligibility criteria met