Exercise for Breast Cancer Cognitive Function

(BRAIN Trial)

Recruiting at 3 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Stroke, Neurological disorders, Brain surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 32

Duration: 24 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is aerobic exercise safe for breast cancer patients?

Aerobic exercise has been studied in breast cancer patients and is generally considered safe. A study on metastatic breast cancer patients found aerobic training to be feasible and safe. ^{1 2 3 4 5}

How does aerobic exercise training differ from other treatments for cognitive function in breast cancer patients?

Aerobic exercise training is unique because it is a non-drug approach that may improve cognitive function in breast cancer patients by enhancing physical activity and cardiorespiratory fitness, which are linked to better cognitive outcomes. Unlike other treatments, it is a low-cost, adaptable method that can be easily integrated into daily life and has shown promise in improving cognitive function in both healthy older adults and those with cognitive impairments. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Aerobic Exercise Training for improving cognitive function in breast cancer patients?

Research suggests that aerobic exercise may improve cognitive function in breast cancer patients, as it has been associated with better attention, memory, and processing speed. Studies have shown that physical activity and cardiorespiratory fitness are linked to improved cognitive abilities in postmenopausal women with breast cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Diane K. Ehlers, Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have exercised for 20 minutes or more on only 2 days or less per week in the last six months.

You do not show signs of possible memory or thinking problems based on a test called the Telephone Interview of Cognitive Status (TICS-M).

Physician's clearance to participate in an exercise program

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a community-based aerobic exercise intervention or health education program for 6 months

24 weeks

20 supervised sessions for exercise group; up to 9 monthly classes/webinars for health education group

Follow-up

Participants are monitored for cognitive function and other health outcomes after the intervention

6 months

Follow-up assessments at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise Training
• Health Education

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm I (Aerobic Exercise) Experimental Treatment 1 Intervention

Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo MRI and wear an accelerometer throughout the study.

Group II: Arm II (Health Education) Active Control 1 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.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The EPICC Study is a randomized controlled trial involving 254 postmenopausal women with early-stage breast cancer, testing the impact of a six-month moderate-intensity aerobic exercise program on cognitive function during aromatase inhibitor therapy.

This study aims to address cognitive impairment, which affects up to 75% of breast cancer survivors, and if successful, could establish exercise as a low-cost, adaptable intervention to improve cognitive health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Exercise Program in Cancer and Cognition (EPICC): A randomized controlled trial of the effects of aerobic exercise on cognitive function in postmenopausal women with breast cancer receiving aromatase inhibitor therapy. Gentry, AL., Erickson, KI., Sereika, SM., et al.[2023]

The ACTIVATE trial is investigating the effects of supervised aerobic exercise on cognitive changes related to chemotherapy in women with breast cancer, aiming to determine if exercise can prevent or manage these cognitive issues during treatment.

This randomized controlled trial will assess cognitive functioning and quality of life at multiple points during and after chemotherapy, potentially supporting aerobic exercise as a beneficial intervention for women experiencing chemotherapy-related cognitive changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol of the Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial: a two-arm, two-centre randomized controlled trial. Brunet, J., Barrett-Bernstein, M., Zadravec, K., et al.[2021]

In a study of 73 postmenopausal women with early-stage breast cancer, higher levels of physical activity were linked to improved cognitive functions such as attention, visual memory, and psychomotor speed.

Better cardiorespiratory fitness, measured by peak maximum VO2, was associated with enhanced concentration, verbal memory, and working memory, suggesting that both physical activity and fitness may positively impact cognitive health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, cardiorespiratory fitness, and cognitive function in postmenopausal women with breast cancer. Bender, CM., Sereika, SM., Gentry, AL., et al.[2023]

A 24-week aerobic exercise program for postmenopausal breast cancer survivors showed a significant improvement in processing speed, with participants completing a cognitive test 14.2 seconds faster compared to those who maintained their usual lifestyle.

While self-reported cognitive function did not show significant improvement, brain imaging revealed functional changes in several regions, suggesting that aerobic exercise may positively influence cognitive processing in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise on cancer-associated cognitive impairment: A proof-of-concept RCT. Campbell, KL., Kam, JWY., Neil-Sztramko, SE., et al.[2019]

A 6-month exercise program significantly improved self-reported cognitive functioning, physical fitness, fatigue, quality of life, and depression in breast cancer patients who experienced cognitive problems after chemotherapy, involving 181 participants.

While the exercise did not show a significant effect on overall tested cognitive functioning, it did benefit highly fatigued patients, suggesting that exercise may help improve cognitive issues in this specific subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer: a randomized controlled trial (PAM study). Koevoets, EW., Schagen, SB., de Ruiter, MB., et al.[2022]

Aerobic training was found to be safe for women with metastatic breast cancer, with only 3% of participants lost to follow-up, but the overall attendance rate was lower than the predefined feasibility target, indicating challenges in implementation.

Despite feasibility issues, 42% of patients who completed the aerobic training showed improvements in their peak oxygen consumption (VO2peak) and functional capacity, suggesting potential benefits for select individuals that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. Scott, JM., Iyengar, NM., Nilsen, TS., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Protocol for Exercise Program in Cancer and Cognition (EPICC): A randomized controlled trial of the effects of aerobic exercise on cognitive function in postmenopausal women with breast cancer receiving aromatase inhibitor therapy. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Study protocol of the Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial: a two-arm, two-centre randomized controlled trial. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Physical activity, cardiorespiratory fitness, and cognitive function in postmenopausal women with breast cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise on cancer-associated cognitive impairment: A proof-of-concept RCT. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer: a randomized controlled trial (PAM study). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. [2023]