40 Participants NeededMy employer runs this trial

Exercise + Brain Stimulation for Breast Cancer Survivors

AL
Overseen ByAshley L Artese, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist breast cancer survivors experiencing thinking and memory problems after treatment. It combines regular exercise with a gentle brain stimulation technique called transcranial alternating current stimulation (tACS), which aims to enhance attention and memory. The trial will assess participants' adherence to the program, its safety, and their perceptions, comparing real tACS with a placebo version. Individuals who have completed treatment for non-spreading breast cancer, have noticed memory issues, and are not already engaging in significant exercise may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve cognitive health for breast cancer survivors.

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's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that transcranial alternating current stimulation (tACS) is generally safe and well-tolerated. Studies reported no serious side effects with tACS. Some participants experienced mild, temporary tingling sensations, which are not harmful. Research also indicates that tACS is a safe and non-invasive method for brain stimulation, as it doesn't require surgery.

Exercise, another component of this treatment, is known to be safe and beneficial for health. It improves physical fitness and can enhance mood and brain function. These findings suggest that combining exercise with tACS should be safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Exercise + transcranial alternating current stimulation (Ex+tACS) treatment for breast cancer survivors because it combines physical activity with advanced brain stimulation to potentially enhance cognitive function. Unlike standard care options that might focus solely on physical rehabilitation or cognitive therapies, this approach targets the brain directly through 6Hz alternating current stimulation to the prefrontal cortex. This innovative combination could offer a dual benefit: improving both physical health and cognitive function, which is particularly appealing for breast cancer survivors who often experience cognitive challenges post-treatment.

What evidence suggests that the Exercise + transcranial alternating current stimulation (Ex+tACS) intervention could be effective for cancer-related cognitive impairment in breast cancer survivors?

Research has shown that combining exercise with brain stimulation, such as transcranial alternating current stimulation (tACS), may enhance thinking skills in cancer survivors. In this trial, participants in the intervention arm will receive Exercise + tACS (Ex+tACS), targeting the brain's prefrontal cortex, which is crucial for planning and decision-making. Studies have found that similar brain stimulation methods can improve attention and memory in individuals who have faced cognitive difficulties after cancer treatment. For instance, survivors reported better focus after receiving this type of non-invasive brain stimulation. This approach is believed to boost brain activity and help reduce cognitive problems related to cancer treatment.12678

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who feel they have problems with memory or thinking after treatment. Participants should be able to safely exercise and not have any conditions that would make brain stimulation unsafe, such as certain neurological disorders or implanted medical devices.

Inclusion Criteria

I finished my main breast cancer treatment at least 3 months ago.
I am a breast cancer survivor with memory or thinking problems after treatment.
I am 18 or older and have had non-metastatic breast cancer (stage 0-3).

Exclusion Criteria

Current participation in aerobic exercise for ≥60 min/week
Contraindication or impairment that precludes the potential participant from exercise as defined by the American College of Sports Medicine
I have heart disease that is not well controlled.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week intervention combining exercise and transcranial alternating current stimulation (Ex+tACS) or exercise with placebo tACS

4 weeks
3 visits per week (in-person)

Follow-up

Participants are monitored for changes in cognitive and physical function post-intervention

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Exercise + transcranial alternating current stimulation (Ex+tACS)

Trial Overview

The study tests if a 4-week program combining exercise with noninvasive brain stimulation (tACS) is practical and safe for breast cancer survivors. One group gets real tACS during exercise; the other gets a placebo version of tACS while exercising.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention ArmExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida Atlantic University

Lead Sponsor

Trials
35
Recruited
10,700+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials
1,998
Recruited
602,000+

Florida Department of Health

Collaborator

Trials
30
Recruited
13,000+

Citations

Exploring the Feasibility of an Exercise and Noninvasive ...

This study will assess the feasibility of a 4-week Ex+tACS intervention in breast cancer survivors who report cancer-related cognitive ...

Exploring the Feasibility of an Exercise and Noninvasive Brain ...

The purpose of this study is to assess the feasibility of a 4-week intervention combining exercise and transcranial alternating current ...

Impact of transcranial direct current stimulation on sustained ...

Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties in survivors with cancer- ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32353419/

Impact of transcranial direct current stimulation on sustained ...

Results: Stimulation was feasible and tolerable, with 89% of participants completing all sessions, and none reporting more than mild to moderate discomfort.

(PDF) Effects of transcranial direct current stimulation on ...

In this case report, we present a Brazilian Latin American Woman, 71 years, breast-cancer survivor with cognitive complaints after adjuvant ...

Transcranial alternating current stimulation for treating ... - PMC

The primary outcome was met by 80% of the active-tACS group (32/40) and 10% of the sham group (4/40). The active group also showed significantly ...

Exploring the Feasibility of an Exercise and Noninvasive ...

The purpose of this study is to assess the feasibility of a 4-week intervention combining exercise and transcranial alternating current stimulation (Ex+tACS) in ...

Effect of add-on transcranial alternating current stimulation ...

No serious adverse events were observed in this trial. The reported general side effects in the active tACS group (compared with the sham tACS group) included ...