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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Withdrawn

Conditions

Neuropathy

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03436680
NCI-2018-01049 (Registry Identifier)
P30CA016672 (U.S. NIH Grant/Contract)
2017-0309 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Group I (neurofeedback)
Experimental group
Description:
Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks.
Treatment:
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Other: Best Practice
Behavioral: Neurofeedback
Group II (standard of care)
Active Comparator group
Description:
Participants receive standard of care.
Treatment:
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Other: Best Practice

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems