Back to resultsHome-Based Neurofeedback Program in Treating Participants With Chemotherapy-Induced Peripheral Neuropathy
Primary Purpose
Neuropathy
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Best Practice
Neurofeedback
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Neuropathy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I (neurofeedback)
Group II (standard of care)
Arm Description
Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks.
Participants receive standard of care.
Outcomes
Primary Outcome Measures
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%).
Secondary Outcome Measures
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.
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,
Effects of Home-Based Neurofeedback (HBNF) on Other Aspects of Cancer-Related Symptoms Using Patient Surveys
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.
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).
Full Information
NCT ID
NCT03436680
First Posted
January 26, 2018
Last Updated
February 16, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03436680
Brief Title
Home-Based Neurofeedback Program in Treating Participants With Chemotherapy-Induced Peripheral Neuropathy
Official Title
Feasibility of Home-Based Neurofeedback to Treat Chemotherapy-Induced Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Due to lack of funds, time, and staff cannot activate the study.
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (neurofeedback)
Arm Type
Experimental
Arm Description
Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks.
Arm Title
Group II (standard of care)
Arm Type
Active Comparator
Arm Description
Participants receive standard of care.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
EEG biofeedback
Intervention Description
Complete neurofeedback training sessions
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of a Home-Based Neurofeedback (HBNF) System
Description
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 Outcome Measure Information:
Title
Effects of Home-Based Neurofeedback (HBNF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) Versus a Waitlist (WL) Control Group in Cancer Patients
Description
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
Title
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
Title
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.
Title
Effects of Home-Based Neurofeedback (HBNF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) Versus a Waitlist (WL) Control Group in Cancer Patients
Description
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Prinsloo
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Home-Based Neurofeedback Program in Treating Participants With Chemotherapy-Induced Peripheral Neuropathy
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