WithdrawnNCT03436680Updated Mar 4, 2022

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

An interventional study of Best Practice and Neurofeedback in Neuropathy, sponsored by M.D. Anderson Cancer Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-04.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care

Why this study was withdrawn

Due to lack of funds, time, and staff cannot activate the study.

Phase: Not applicable
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Neuropathy

Browse trials for

Peripheral Nervous System Diseases 1,003

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Experimental
Group I (neurofeedback)
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
Active comparator
Group II (standard of care)
Participants receive standard of care.
Other: Best Practice · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

OtherBest Practice
Receive standard of care
Also known as: standard of care, standard therapy
BehavioralNeurofeedback
Complete neurofeedback training sessions
Also known as: EEG biofeedback
OtherQuality-of-Life Assessment
Ancillary studies
Also known as: Quality of Life Assessment
OtherQuestionnaire Administration
Ancillary studies

What researchers measure

Primary outcomes

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%).
Time frame: 6 weeks

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

Registry details

Key details

Study ID: NCT03436680
Lead sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Feb 19, 2018
Start date: Sep 1, 2020 (estimated)
Primary completion: Dec 31, 2020 (estimated)
Completion: Dec 31, 2021 (estimated)
Last update: Mar 4, 2022

Study contacts

Sarah Prinsloo

principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peripheral Nervous System Diseases→

Other studies from this sponsor

M.D. Anderson Cancer Center

Start the discussion