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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
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 belowSelect...
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:Select...
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.
Select...
My breast cancer is either very early stage or has spread to other parts of my body.
Select...
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)
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 moreTrial 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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,840 Total Patients Enrolled
944 Trials studying Breast Cancer
1,543,804 Patients Enrolled for Breast Cancer
University of NebraskaLead Sponsor
554 Previous Clinical Trials
1,145,276 Total Patients Enrolled
14 Trials studying Breast Cancer
1,006,143 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,285 Total Patients Enrolled
83 Trials studying Breast Cancer
14,636 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have exercised for 20 minutes or more on only 2 days or less per week in the last six months.I am willing to follow all study requirements.I cannot travel often to the study site for treatments and tests.Your MRI scan shows a significant abnormality in your brain that needs medical follow-up.I have had a stroke, TIA, brain surgery, or other neurological disorders.You do not show signs of possible memory or thinking problems based on a test called the Telephone Interview of Cognitive Status (TICS-M).I have been diagnosed with a second cancer, not including non-invasive skin cancers.I am unwilling or unable to return to the hospital where I was enrolled for follow-up visits.You don't exercise regularly, like taking walks or playing sports, for at least 20 minutes on only 2 days or less per week in the last 6 months.You scored higher than 21 on the Telephone Interview of Cognitive status (TICS-M) test.I agree to possibly being assigned to an exercise or a control group.I was pre- or peri-menopausal when diagnosed with breast cancer.You have a significant score on a test for thinking and memory skills.My first cancer diagnosis is Stage I-IIIa breast cancer.I am currently undergoing or recently finished cancer treatment, or it's been over 2 years since my primary treatment.I cannot or do not want to use an activity tracker regularly during the study.I am scheduled for surgery during the study period.I have been post-menopausal since my diagnosis.I finished my main cancer treatment between 3 and 24 months ago.I am not willing to be assigned randomly to an exercise or health education group.My breast cancer is either very early stage or has spread to other parts of my body.I finished my main cancer treatments between 6-24 months ago but may still be on hormonal therapy.You are currently participating in another exercise program.I need help or devices to walk.I was post-menopausal when my cancer was diagnosed.I can complete assessments on my own or with help.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (Health Education)
- Group 2: Arm I (Aerobic Exercise)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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