What side effects are associated with this type of intervention?

Common treatments for breast cancer include chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Chemotherapy can cause side effects such as nausea, fatigue, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and swelling. Hormone therapy can result in hot flashes, mood swings, and increased risk of blood clots. Targeted therapy often causes fewer side effects but can include diarrhea, liver problems, and skin rashes. Transcranial Direct Current Stimulation (tDCS) is being studied for cognitive function improvement in breast cancer survivors, and its side effects are generally mild, including skin irritation at the electrode site and mild headaches.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer primarily include chemotherapeutic agents, targeted therapies, and hormone therapies. Notable drugs include T-DM1 (ado-trastuzumab emtansine), which is used for HER2-positive breast cancer and has shown efficacy in patients with brain metastases. While T-DM1 is not a neuromodulation therapy like tDCS, it represents an advanced targeted treatment option. Currently, there are no FDA-approved neuromodulation treatments specifically for breast cancer, but ongoing research explores the potential of techniques like tDCS for cognitive rehabilitation in cancer survivors.

What other types of research exist?

Promising alternatives to tDCS for improving cognitive functions in breast cancer patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in various cognitive and neurological conditions; 2) Deep Brain Stimulation (DBS), although more invasive, has been effective in other disorders and may offer benefits; 3) Sulforaphane treatment, derived from broccoli sprouts, has shown some promise in cognitive improvement and neuroprotection. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

← Back to Search

Device

tDCS + Cognitive Training for Breast Cancer Survivors

N/A

Waitlist Available

Led By James Root, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients with prior history of primary Central Nervous System (CNS) cancer or CNS metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called transcranial direct current stimulation (tDCS) on breast cancer survivors. tDCS uses a small electrical current to stimulate the brain. The goal is to see if this can help improve memory in these patients.

Who is the study for?

This trial is for breast cancer survivors aged 40-65 who finished chemotherapy at least six months ago, have no current evidence of disease, and may or may not be on endocrine therapy. They should self-report memory or cognitive issues post-treatment and must understand English. Excluded are those with pacemakers, neurological illnesses, pregnancy/breastfeeding status, schizophrenia, bipolar disorder, untreated depression/anxiety, or a history of CNS cancer.

What is being tested?

The study tests the feasibility of using transcranial direct current stimulation (tDCS) alongside cognitive training to help improve memory in breast cancer survivors. It's a pilot study aimed at determining if this approach can be part of memory rehabilitation.

What are the potential side effects?

While tDCS is generally considered safe with minimal side effects such as mild tingling or itching under the electrode site during treatment; headache and fatigue might occur but typically resolve shortly after sessions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had brain cancer or cancer that spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

number of subjects recruited

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673

back pain flair up

Myasthenia Gravis

100%

80%

60%

40%

20%

Study treatment Arm

tDCS + Robotic Arm Therapy

tDCS Sham + Robotic Arm Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: tDCS with cognitive trainingExperimental Treatment2 Interventions

We will collect: 1) self-reported demographic information (\~5 min) 2) cognitive functioning data (PAOFI) at session 1 and session 4 (\~10min) \[60\]; 3) behavioral data and EEG data from the tDCS stimulation task for each session (downloaded by investigators); 4) patient feedback on their experience with tDCS (tDCS Patient Experience Questionnaire (tPEQ)) for each session (\~5 min); 5) tDCS accrual and session completion rates at the completion of treatment and 6) Brunoni Adverse Events Questionnaire (\~5 min)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaires

2013

Completed Phase 2

~4280

Transcranial Direct Current Stimulation (tDCS)

2016

Completed Phase 2

~2150

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves the physical removal of the tumor, while chemotherapy uses drugs to kill rapidly dividing cancer cells. Radiation therapy employs high-energy rays to destroy cancer cells. Hormone therapy blocks hormones like estrogen that fuel certain types of breast cancer, and targeted therapy uses drugs to target specific molecules involved in cancer growth. These treatments are crucial for breast cancer patients as they aim to eliminate cancer, prevent recurrence, and improve survival rates. Similar to how tDCS modulates neuronal activity to improve cognitive functions, these treatments target specific aspects of cancer biology to achieve therapeutic effects.

Does transcranial direct current stimulation enhance cognitive performance in Parkinson's disease mild cognitive impairment? An event-related potentials and neuropsychological assessment study.Frontal Transcranial Direct Current Stimulation as a Potential Treatment of Parkinson's Disease-Related Fatigue.Transcranial direct current stimulation in schizophrenia.