NeuropathyNCT03436680
Home-Based Neurofeedback Program in Treating Participants With Chemotherapy-Induced Peripheral Neuropathy
A study testing Best Practice, Neurofeedback and Quality-of-Life Assessment in people with Neuropathy, run by M.D. Anderson Cancer Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy
- What is being tested?
- Best Practice, Neurofeedback and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the feasibility of using a home-based neurofeedback system and dry electroencephalography (EEG) cap to treat chemotherapy-induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
- 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
- Neuropathy
- Being tested
- Best Practice, Neurofeedback, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
NeurofeedbackBehavioural
Also called EEG biofeedback
Complete neurofeedback training sessions
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (neurofeedback) | Experimental | Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks. Receives: 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. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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
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.
Measured: 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,
Measured: Baseline and at 6 weeks
Effects of Home-Based Neurofeedback (HBNF) on Other Aspects of Cancer-Related Symptoms Using Patient Surveys
Measured: 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.
Measured: 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).
Measured: Baseline and at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Due to lack of funds, time, and staff cannot activate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sarah Prinsloo, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436680
- Sponsor's protocol ID
- 2017-0309
- Other IDs
- NCI-2018-01049, 2017-0309, P30CA016672
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2018
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-Based Neurofeedback to Treat Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03436680
- Acronym / sponsor ID
- 2017-0309
- Conditions
- Neuropathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to lack of funds, time, and staff cannot activate the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Examine the feasibility of using a home-based neurofeedback system and dry electroencephalography (EEG) cap to treat chemotherapy-induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (neurofeedback) | Experimental | Other: Best Practice, Behavioral: Neurofeedback, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks. |
| Group II (standard of care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Group I (neurofeedback), Group II (standard of care) |
| NeurofeedbackAlso: EEG biofeedbackComplete neurofeedback training sessions | Behavioural | Group I (neurofeedback) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (neurofeedback), Group II (standard of care) |
| Questionnaire AdministrationAncillary studies | Other | Group I (neurofeedback), Group II (standard of care) |
Primary outcome
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%).
5 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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Prinsloo principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Neurofeedback and Quality-of-Life Assessment in people with Neuropathy, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a Home-Based Neurofeedback (HBNF) System (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.