Home-Based Neurofeedback Program in Treating Participants With Chemotherapy-Induced Peripheral Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-31

Brief Summary

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This trial studies how well a home-based neurofeedback program works in treating participants with chemotherapy-induced peripheral neuropathy (nerve damage that affects motor function). Neurofeedback training is a type of therapy that uses an electroencephalograph and a computer software program to measure brain wave activity. It may help teach participants how to change their own brain waves to lower their perception of pain symptoms and improve overall quality of life.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Examine the feasibility of using a home-based neurofeedback system and dry electroencephalography (EEG) cap to treat chemotherapy-induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. Estimate the effects of home-based neurofeedback (HBNF) on symptoms of (CIPN) versus a wait list (WL) control group in cancer patients.

II. Estimate the effects of home-based neurofeedback (HBNF), versus WL, on the cortical and subcortical brain regions associated with CIPN.

III. Estimate the effects of a HBNF on other aspects of pain, cancer-related symptoms, quality of life (QOL), and mental health.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks.

GROUP II: Participants receive standard of care.

After completion of study, participants are followed up at 1 week for Group I and 6 weeks for Group II.

Conditions

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Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (neurofeedback)

Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive standard of care

Neurofeedback

Intervention Type BEHAVIORAL

Complete neurofeedback training sessions

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (standard of care)

Participants receive standard of care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard of care

Intervention Type OTHER

Neurofeedback

Complete neurofeedback training sessions

Intervention Type BEHAVIORAL

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy EEG biofeedback Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Neuropathic pain score \>= 4 on a 0-10 numeric pain scale (numeric rating scale \[NRS\]) and/or grade 3 or higher neuropathic symptoms according to the National Cancer Institute's 4 point grading scale.
* Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician).
* Patients must have had neuropathic symptoms for a minimum of 3 months.
* No plans to change pain medication regimen during the course of the study.
* Off active chemotherapy treatment for minimum of 6 months.
* Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.) therapies allowed as long as they will be continued during the course of the study.
* Willing to come to MD Anderson for the intake and follow up data acquisition and to receive their equipment.
* Willing to allow research staff to come to their homes or to return the equipment to MD Anderson (MDA) in the case of equipment malfunction.
* Have had a diagnosis of cancer treated with chemotherapy.
* Live within a 50 mile radius of MD Anderson's main campus.

Exclusion Criteria

* Patients who are taking any antipsychotic medications.
* Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.
* Patients who have ever been diagnosed with bipolar disorder or schizophrenia.
* Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy.
* Patients who have a history of head injury or who have known seizure activity.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No