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

NCT03436680 | Withdrawn DMC

• 3 other identifiers: 2017-0309NCI-2018-01049P30CA016672
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuropathy

Outcome Measures

Primary Outcomes (1)

• Feasibility of a Home-Based Neurofeedback (HBNF) System

  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 Outcomes (5)

• Effects of Home-Based Neurofeedback (HBNF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) Versus a Waitlist (WL) Control Group in Cancer Patients

  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,

  Baseline and at 6 weeks

• Effects of Home-Based Neurofeedback (HBNF) on Other Aspects of Cancer-Related Symptoms Using Patient Surveys

  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

  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).

  Baseline and at 6 weeks

Study Arms (2)

Group I (neurofeedback)

EXPERIMENTAL

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

Other: Best Practice; Behavioral: Neurofeedback; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (standard of care)

ACTIVE COMPARATOR

Participants receive standard of care.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Group I (neurofeedback); Group II (standard of care)

Neurofeedback BEHAVIORAL

Complete neurofeedback training sessions

Also known as: EEG biofeedback

Group I (neurofeedback)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (neurofeedback); Group II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Group I (neurofeedback); Group II (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Neurofeedback

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Sarah Prinsloo

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 19, 2018
• Study Start: September 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-02