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

February 16, 2022 updated by: M.D. Anderson Cancer Center

Feasibility of Home-Based Neurofeedback to Treat Chemotherapy-Induced Peripheral Neuropathy

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (neurofeedback)
Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy
Behavioral: Neurofeedback
Complete neurofeedback training sessions
Other Names:
  • EEG biofeedback
Active Comparator: Group II (standard of care)
Participants receive standard of care.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of a Home-Based Neurofeedback (HBNF) System
Time Frame: 6 weeks
HBNF intervention feasible if the average number of HBNF sessions completed across patients in the HBNF arm is >= 15.0 (or on average the proportion of sessions completed is >= 75%).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Home-Based Neurofeedback (HBNF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) Versus a Waitlist (WL) Control Group in Cancer Patients
Time Frame: Baseline and at 6 weeks
Summary statistics and 90% confidence intervals calculated for the Pain Quality Assessment Scale (PQAS) rated from 0 - 10 by study arm at baseline and at the end of treatment.
Baseline and at 6 weeks
Effects of Neurofeedback on the Cortical and Subcortical Brain Regions Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Effects of Home-Based Neurofeedback (HBNF) versus Waitlist (WL) Control Group determined by EEG,
Time Frame: Baseline and at 6 weeks
Baseline and at 6 weeks
Effects of Home-Based Neurofeedback (HBNF) on Other Aspects of Cancer-Related Symptoms Using Patient Surveys
Time Frame: Baseline and within 7 days of the conclusion of treatment.
Baseline and within 7 days of the conclusion of treatment.
Effects of Home-Based Neurofeedback (HBNF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) Versus a Waitlist (WL) Control Group in Cancer Patients
Time Frame: Baseline and at 6 weeks
Summary statistics and 90% confidence intervals calculated for the Brief Pain Inventory Short Form (BPI) by study arm at baseline and at the end of treatment.
Baseline and at 6 weeks
Effects of Neurofeedback on the Cortical and Subcortical Brain Regions Associated with CIPN Determined by Changes in EEG as Measured by Low Resolution Electromagnetic Tomography (LORETA).
Time Frame: Baseline and at 6 weeks
Baseline and at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0309 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2018-01049 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuropathy

Clinical Trials on Quality-of-Life Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe