Exercise for Cognitive Impairment in Breast Cancer Survivors

(ICAN Trial)

Overseen By Hava Barkai

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Tamoxifen, Aromatase inhibitors

Disqualifiers: Unsafe medical condition, 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: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a year-long exercise program can improve thinking and memory in breast cancer survivors. Participants will either follow a personalized exercise plan or a general health and wellness program, which serves as the control group. The trial seeks breast cancer survivors who completed treatment at least six months ago and have experienced memory or thinking issues since their diagnosis. Participants should also be less active than recommended and possess a Fitbit-compatible device with internet access. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could enhance the quality of life for breast cancer survivors.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you plan to stop taking tamoxifen or an aromatase inhibitor in the next 6 months.

What prior data suggests that this exercise intervention is safe for breast cancer survivors?

Past studies have shown that exercise is generally safe for breast cancer survivors. Research indicates that physical activity can enhance brain function without causing serious side effects. For instance, studies have found that aerobic exercise, such as walking or cycling, can improve memory and attention in women who have had breast cancer. Reports from these studies reveal that participants managed the exercise programs well, experiencing few, if any, negative effects.

Additionally, exercise is often recommended for improving overall health, including mental health. Healthcare providers frequently suggest it for people recovering from cancer. While some participants might experience minor issues like sore muscles or tiredness, these are usually temporary and manageable. Overall, the evidence suggests that exercise is a safe and effective way to support brain health in breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise program for cognitive impairment in breast cancer survivors because it offers a non-pharmaceutical approach to improve brain health. Unlike medications typically used for cognitive issues, this program is personalized and delivered through phone and email, making it highly accessible and adaptable to individual needs. Additionally, the focus on exercise as a treatment harnesses the body's natural ability to enhance cognitive function, potentially reducing side effects associated with drugs. This innovative approach could provide a sustainable, holistic option for those seeking to improve their cognitive health post-treatment.

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

Research has shown that exercise can improve brain function in breast cancer survivors. Several studies have found that staying active leads to better self-reported thinking skills, decision-making, and speed of processing information. In this trial, participants in the Exercise Intervention arm will receive a 12-month individually tailored phone and email-based exercise program. One study discovered that a 6-month exercise program improved brain function, reduced tiredness, and boosted mood. Another study suggested that physical activity might help prevent brain issues related to chemotherapy. Overall, exercise offers many brain benefits for breast cancer survivors. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who finished treatment at least 6 months ago but within the last 5 years, have low physical activity levels, own a Fitbit-compatible device with internet, and experience cognitive difficulties post-diagnosis. It's not for those with medical conditions that make unsupervised exercise unsafe or those unable to commit to a year-long study.

Inclusion Criteria

Have a Fitbit compatible device with internet

You have trouble thinking clearly since you were diagnosed with cancer.

You don't do much exercise.

Exclusion Criteria

Medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention

Unable to commit to a 12-month study

You are currently taking tamoxifen or an aromatase inhibitor, and you plan to stop taking it within the next 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-month individually tailored phone and email-based exercise program or a health and wellness program

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Exercise

Trial Overview The study is examining if an exercise program can boost brain function in breast cancer survivors. Participants will either engage in this physical activity intervention or be part of a control group without the special exercise regimen.

How Is the Trial Designed?

Group I: Exercise Intervention Experimental Treatment 1 Intervention

This arm will receive a 12-month individually tailored phone and email-based exercise program.

Group II: Health & Wellness Intervention Active Control 1 Intervention

This arm will receive a 12-month health and wellness program.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8976138/

Effects of physical exercise on cognitive function of breast ... Physical exercise can improve cognitive function for breast cancer survivors, particularly in self-reported cognitive function, and executive function.

2. facingourrisk.org facingourrisk.org/XRAY/activity-helps-prevent-cognitive-decline

Study : Physical activity may prevent chemotherapy-related ... Physical activity has been linked with improved health outcomes in cancer survivors. Patients with different types of cancer who engage in ...

3. frontiersin.org frontiersin.org/journals/cognition/articles/10.3389/fcogn.2024.1332960/full

Relationship of physical activity and cognitive functioning ... Greater physical activity was associated with faster processing speed in participants closer in time to their cancer diagnosis. These results ...

4. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-022-01530-2

Effect of physical exercise on cognitive function after ... A 6-month exercise intervention improved self-reported cognitive functioning, physical fitness, fatigue, QoL, and depression in chemotherapy-exposed breast ...

5. journals.lww.com journals.lww.com/ajpmr/fulltext/2024/09000/comparative_effects_of_exercise_interventions_and.3.aspx

Comparative Effects of Exercise Interventions and... Mindfulness-based interventions significantly improve cognitive function in breast cancer survivors (SMD = 0.43, 95% CI: 0.24, 0.63). The meta-analysis showed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8009833/

A randomized trial of physical activity for cognitive functioning ... The I Can! study will examine whether a physical activity intervention improves cognition among 250 post-treatment breast cancer survivors.

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

Acute aerobic exercise effects on cognitive function in breast ... Many breast cancer survivors (BCS) report deficits in cognitive function. Physical activity (PA) has been associated with better processing ...

8. 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 ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.544

The Exercise Cancer and Cognition (ECCO) study. The ECCO study aimed to assess the neuropsychological and brain morphological effects of high-intensity interval training (HIIT) in breast cancer patients.

10. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35540

Aerobic exercise and CogniTIVe functioning in women with ... Aerobic exercise is shown to improve cognitive function and attenuate cognitive decline in older adults and those with mild cognitive impairment ...