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

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ClinicalTrials.gov Identifier: NCT03436680
Recruitment Status : Withdrawn (Due to lack of funds, time, and staff cannot activate the study.)
First Posted : February 19, 2018
Last Update Posted : March 4, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neuropathy Other: Best Practice Behavioral: Neurofeedback Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Home-Based Neurofeedback to Treat Chemotherapy-Induced Peripheral Neuropathy
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Behavioral: Neurofeedback
Complete neurofeedback training sessions
Other Name: EEG biofeedback

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies
Active Comparator: Group II (standard of care)
Participants receive standard of care.
 Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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%).


Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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. ]
  4. 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.

  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436680


Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sarah Prinsloo M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03436680    
Other Study ID Numbers: 2017-0309
NCI-2018-01049 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0309 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases