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Interdisciplinary Interventions for Pain in Head and Neck Cancer

Phase 2

Recruiting

Led By Sriram Yennu

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients currently receiving opioids for at least 1 week

Age 18 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of a year.

Awards & highlights

Study Summary

This trial is testing whether NFB training and CHAT are more effective than the current standard of care in reducing pain and lowering patient use of opioids in head and neck cancer patients.

Who is the study for?

This trial is for adults over 18 with head and neck cancer, scheduled for radiation therapy, who can visit the outpatient center and have a life expectancy of at least one year. Participants must be able to understand English, complete assessments, consent in writing, and currently use opioids. It's not for those with impaired cognition or employees of MD Anderson Cancer Center.Check my eligibility

What is being tested?

The study compares standard pain management care with two interventions: neurofeedback training using EEG to potentially reduce pain by altering brain waves; and CHAT which includes comprehensive support on symptom management and opioid safety.See study design

What are the potential side effects?

While specific side effects are not listed for these interventions, counseling may bring emotional discomfort. Neurofeedback could cause fatigue or headache. Standard care side effects depend on individual treatments but may include typical reactions to medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been taking opioids for pain for at least one week.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of a year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of a year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of a year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of non-medical opioid use (NMOU) behaviors

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ARM II (NFB)Experimental Treatment3 Interventions

Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.

Group II: ARM I (CHAT)Experimental Treatment2 Interventions

Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.

Group III: ARM III (SOC)Active Control2 Interventions

Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electroencephalography

2013

N/A

~790

Neurofeedback

2019

Completed Phase 3

~1030

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,318 Total Patients Enrolled

Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center

12 Previous Clinical Trials

1,485 Total Patients Enrolled

Media Library

Standard of Care Clinical Trial Eligibility Overview. Trial Name: NCT05077072 — Phase 2

Head and Neck Cancers Research Study Groups: ARM I (CHAT), ARM II (NFB), ARM III (SOC)

Head and Neck Cancers Clinical Trial 2023: Standard of Care Highlights & Side Effects. Trial Name: NCT05077072 — Phase 2

Standard of Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077072 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for people to enroll in this experiment?

"The information present on clinicaltrials.gov confirms that this trial is actively seeking participants. The investigation was initially posted on October 8th 2021 and the details have since been amended as recently as October 15th, 2021."

Answered by AI

What is the aggregate headcount for participants involved in this clinical experiment?

"Correct. Clinicaltrials.gov indicates that this clinical research is actively recruiting patients; beginning on October 8th 2021, and most recently updated on the 15th of October 2021. It aims to recruit a total of 72 participants from 1 medical site."

Answered by AI

Has the FDA sanctioned Neurofeedback as a legitimate medical treatment?

"Based on current evidence, Neurofeedback can be rated at 2 due to the Phase 2 trial data that suggests it is safe but unproven in terms of efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

2021. "Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05077072.