Clinical trial NCT02543320: Neurofeedback in Decreasing Acute Radiotherapy-Induced Pain in Patients With Head and Neck Cancer
Official title: Neurofeedback for Acute Radiotherapy-Induced Pain in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-09-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot trial studies how well neurofeedback training works in decreasing acute radiotherapy-induced pain in patients with head and neck cancer. Neurofeedback training is a type of therapy that uses electroencephalograph and a computer software program to measure brain wave activity. Neurofeedback training may help teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the effects of an individualized LORETA (low resolution electromagnetic tomography) Z score neurofeedback program on changes in brain function using EEG (electroencephalography), qEEG (quantitative electroencephalography), and LORETA from immediately before to after each session in patients with head and neck cancer undergoing radiotherapy and experiencing pain.

SECONDARY OBJECTIVES:

I. Examine the effects of an individualized LORETA Z score neurofeedback program on perceptions of radiation-induced pain in head and neck cancer patients from immediately before neurofeedback training to immediately after neurofeedback training.

II. Identify brain regions from qEEG and LORETA that are associated with a non-pain state and then an acute pain state.

III. Examine the relationship between the patient and their spouse or primary caregiver.

OUTLINE:

Beginning at weeks 4 and 5 or 5 and 6 of radiotherapy, patients undergo neurofeedback training once per day (QID) three times per week (TIW) for up to 6 treatments. Patients also complete questionnaires over 10 minutes at baseline and after neurofeedback training.

After completion of study, patients are followed up at 1 week.

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
* Patients must not have pain \> 2 on a scale of 0 - 10 (self report) in the head and neck before starting radiotherapy
* Scheduled to undergo a 6 week course of radiotherapy for head and neck cancer
* No plans to change the type of pain medication during the course of the study

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 head or neck pain from other pain syndromes or chronic pain requiring analgesics
* Patients with a history of seizure disorders

Primary outcomes:
measure: EEG
timeFrame: Baseline up to 1 week
measure: Neurofeeback (LORETA)
timeFrame: Up to 5 years
Secondary outcomes:
measure: The Brief Pain Inventory (Short Form)
timeFrame: Up to 5 years
measure: The Multidimensional Pain Inventory (MPI)
timeFrame: Up to 5 years
measure: The Social Provisions Scale (SPS)
timeFrame: Up to 5 years
measure: M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN):
timeFrame: Up to 5 years
measure: Visual analog scale to assess pain
timeFrame: Up to 5 years
measure: Pain medication use
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sarah Prinsloo
role: PRINCIPAL_INVESTIGATOR
References: