What side effects are associated with this type of intervention?

Common cancer treatments, particularly chemotherapy, can lead to a range of side effects including chemotherapy-induced cognitive deficits (CICD) that affect executive functions. Other systemic treatments can cause alopecia, headaches, scalp pain, and feelings of coldness. Peripheral neuropathy, characterized by sensory and motor dysfunctions, is also prevalent. These side effects can significantly impact the patient's quality of life.

What prior FDA approvals exist?

FDA approvals for cancer treatments have included a variety of drugs and therapies aimed at targeting specific cancer types and mechanisms. While direct neuro-modulation techniques for cancer therapy are still under investigation, several drugs have been approved that indirectly affect neuronal activity or cognitive function. For example, T-DM1 (ado-trastuzumab emtansine) has been approved for HER2-positive breast cancer and has shown efficacy in treating brain metastases, which can impact cognitive function. Additionally, treatments like memantine, although primarily for Alzheimer's disease, have been explored for their neuroprotective effects in cancer patients experiencing cognitive deficits due to chemotherapy. Overall, the FDA has approved numerous targeted therapies and chemotherapeutic agents that contribute to managing cancer and its neurological impacts.

What other types of research exist?

Promising novel alternatives to neuro-modulation for cancer patients include: 1) Gene therapy approaches targeting malignant gliomas with updated therapeutic genes, vectors, and delivery systems. 2) Emerging targeted treatments such as temozolomide in combination with radiotherapy, and agents targeting specific mutations like BRAFV600E inhibitors (e.g., trametinib). 3) Novel therapeutics including new cytotoxic agents and their combinations, as well as drugs like cystemustine for high-grade brain tumors. 4) Systemic treatments for recurrent meningiomas, including mTORC1 inhibitors, PD-1 blockade with nivolumab, and combination therapies like everolimus with octreotide.

← Back to Search

Neuro-modulation

Neuromodulation for Chemotherapy-Induced Cognitive Impairment

Q: What is the mechanism of action of this treatment?

Common cancer treatments include neuro-modulation, traditional chemotherapy, and targeted therapies. Neuro-modulation techniques aim to alleviate chemotherapy-induced cognitive deficits by altering neuronal activity. Traditional chemotherapy targets rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as those affecting calcium signaling pathways, aim to specifically target cancer cells with fewer side effects. Understanding these mechanisms is crucial for cancer patients as it helps in selecting treatments that effectively target the cancer while minimizing cognitive and other side effects, thereby improving overall quality of life.

N/A

Waitlist Available

Led By Sneha Phadke, DO

Research Sponsored by Sneha Phadke

Eligibility Criteria Checklist

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

Must have

Women or men with a history of non-metastatic cancer who have completed definitive curative cancer therapy

≥ 18 years of age at time of cancer diagnosis and receipt of chemotherapy

Must not have

History of childhood cancer or receipt of chemotherapy in childhood (<age 18). Developmental insult to the PFC, can be associated with long-term, durable and sometime debilitating cognitive deficits. Hence, we avoid any cognitive confounds that maybe related to this issue.

Patients receiving maintenance systemic therapy for cancer, other than endocrine therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a brain stimulation technique that uses magnetic pulses to improve brain function. It targets patients who have cognitive problems due to chemotherapy. The goal is to see if this treatment can help with higher-order thinking skills by changing brain activity. This noninvasive technique has been used in various therapeutic contexts.

Who is the study for?

This trial is for adults who've had non-metastatic cancer, finished curative therapy including chemotherapy at least a month ago, and are experiencing 'chemo-brain' symptoms like memory issues or trouble concentrating. They must be able to consent and follow study procedures but can't join if they're pregnant, over 250 lbs., need benzodiazepines for MRI anxiety, have metal implants incompatible with MRI/TMS, history of seizures/epilepsy/concussions, active substance use (except tobacco), brain metastasis/tumor history or ongoing metastatic disease.

What is being tested?

The trial tests accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) as a potential treatment to improve cognitive functions affected by chemotherapy. It focuses on executive functions such as decision-making and problem-solving in those reporting 'chemo-brain'.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the scalp, headache, lightheadedness or dizziness during iTBS sessions. There's also a small risk of seizure although this is rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had cancer that did not spread and have completed all treatments aimed at curing it.

Select...

I was 18 or older when diagnosed with cancer and received chemotherapy.

Select...

I experience memory and concentration issues due to chemotherapy.

Exclusion Criteria

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

Select...

I have never had cancer or chemotherapy before turning 18.

Select...

I am on maintenance therapy for cancer, not including hormone therapy.

Select...

I have had brain surgery or radiation for my brain.

Select...

I have or had brain metastasis.

Select...

My cancer has come back or spread to other parts of my body.

Select...

I have or had a brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 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

Mean changes in brain metabolite concentrations between pre and post application of iTBS treatment protocol

Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol

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: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or shamExperimental Treatment1 Intervention

Patients will participate in the prospective longitudinal research protocol over a period of 1.5 months. Treatment will include 8 visits of either accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or iTBS sham stimulation. Patients will be informed that iTBS sham stimulations will be part of the protocol (but will be blind to when treatment/sham will be administered).

0 / 9Eligibility 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

Common cancer treatments include neuro-modulation, traditional chemotherapy, and targeted therapies. Neuro-modulation techniques aim to alleviate chemotherapy-induced cognitive deficits by altering neuronal activity. Traditional chemotherapy targets rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as those affecting calcium signaling pathways, aim to specifically target cancer cells with fewer side effects. Understanding these mechanisms is crucial for cancer patients as it helps in selecting treatments that effectively target the cancer while minimizing cognitive and other side effects, thereby improving overall quality of life.

Calcium transport and signalling in breast cancer: Functional and prognostic significance.Precision Oncology Framework for Investigation of Exercise As Treatment for Cancer.