Exercise for Breast Cancer Cognitive Function

(BRAIN Trial)

Recruiting at 3 trial locations

Overseen By Melissa Cole, MS

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 trial aims to determine if regular aerobic exercise (Aerobic Exercise Training) can enhance memory, focus, and brain health in women who have survived breast cancer. Many of these women face memory and attention challenges after treatment, and exercise might offer relief. Participants will either join an exercise program or attend health education sessions to evaluate which approach proves more effective. Women treated for stage I-IIIa breast cancer who currently engage in minimal exercise may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore the potential benefits of exercise on cognitive health following cancer treatment.

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.

What prior data suggests that aerobic exercise training and health education are safe for breast cancer survivors?

Research shows that aerobic exercise is generally safe and well-tolerated for breast cancer survivors. Studies have found that moderate-intensity aerobic exercise can enhance both physical and mental health without major side effects. For instance, a single exercise session can boost mood and physical well-being. Additionally, aerobic exercise can help manage certain body chemicals related to inflammation and the immune system, such as CRP and IL-6.

While the studies mainly highlight the benefits, they consistently emphasize the safety and tolerability of aerobic exercise for breast cancer survivors. This makes it a promising option for those seeking to improve brain function after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cognitive function issues in breast cancer patients involve medications or cognitive therapies. However, aerobic exercise is gaining attention because it offers a natural, non-invasive approach that might improve cognitive function by boosting blood flow to the brain and releasing endorphins. Unlike standard treatments, aerobic exercise has the added benefit of enhancing overall physical health and potentially improving mood and energy levels, which are often affected during cancer treatment. Researchers are excited because this approach could offer a holistic way to support cognitive health without the side effects associated with medication.

What evidence suggests that aerobic exercise training might be an effective treatment for cognitive impairment in breast cancer survivors?

Research has shown that aerobic exercise, which participants in this trial may receive, can improve thinking skills in breast cancer survivors. One study found that activities like walking or cycling enhanced memory and focus. Other research suggests that aerobic exercise may boost brain function after breast cancer treatment. Even short periods of exercise have been linked to better mental and physical health for survivors. These findings suggest that aerobic exercise could effectively address cognitive challenges related to cancer. Meanwhile, another group in this trial will receive health education, which may also contribute to overall well-being. ^{1 4 5 6 7}

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

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11694240/

Aerobic exercise and CogniTIVe functioning in women with ... Among women initiating chemotherapy for breast cancer, aerobic exercise did not result in significant differences in objective cognitive ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0960977622000686

Effects of physical exercise on cognitive function of breast ... Physical exercise can improve cognitive function among breast cancer survivors. •. Aerobic exercise and combined exercise intervention were more effective ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e104378

Enhancing cognitive function in breast cancer survivors ... Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06540612

Effects of Aerobic Exercise on Cancer-Related Biomarkers ... Exercise program in women diagnosed with breast cancer in remission positively affects the levels of circulating biomarkers CRP, IGF-1, insulin, leptin, IL-6, ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5589-1

Acute aerobic exercise effects on cognitive function in breast ... In breast cancer survivors specifically, several studies have indicated that an acute bout of exercise may improve psychological and physical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5877817/

a randomized controlled trial of the effects of aerobic ... The main purpose of EPICC is to examine whether moderate-intensity aerobic exercise, initiated before beginning AI therapy, can improve cognitive function in ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-09939

Aerobic Exercise Intervention for the Improvement of ... 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 ...