Pain management interventions for head and neck cancer patients
Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients
This study tests three different ways to manage pain for head and neck cancer patients who might misuse opioids to see which method helps them feel better and reduces their pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05077072 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of three different pain management interventions for patients with head and neck cancer who are at risk of non-medical opioid use. Participants are randomized into one of three groups: standard of care, neurofeedback training, or a compassionate high alert team intervention. The study aims to assess adherence rates, frequency of non-medical opioid use, pain severity, and mood changes over a three-month period. Additionally, it explores the brain activity changes associated with these interventions using electroencephalography.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with head and neck cancer who are scheduled to receive radiation therapy and have a history of non-medical opioid use.
Not a fit: Patients with significant cognitive impairment or those who are employees of the M.D. Anderson Cancer Center may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide innovative pain management strategies that reduce reliance on opioids for head and neck cancer patients.
How similar studies have performed: Other studies have shown promise in using neurofeedback and supportive care interventions for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of HNC, with patient scheduled to receive radiation therapy, with or without evidence of active disease * Willingness to be seen in the outpatient supportive care center (SCC) * History of use of non-medical opioid use (Screener and Opioid Assessment for Patients with Pain \[SOAPP\] \>= 7+ and/or Cut Down, Annoyed, Guilty, and Eye opener questionnaire \[CAGE\] \>= 2+) * Physician-estimated prognosis of at least 12 months * Age 18 or older * Able to complete study assessments * Willing to sign written informed consent * Both human papillomavirus (HPV) and non-HPV patients will be included * Patients currently receiving opioids for at least 1 week * Able to read, write and speak English Exclusion Criteria: * Individual with clinically evident impaired cognition by Memorial Delirium Assessment Scale (MDAS) score of \>= 13 * Employees of MD Anderson Cancer Center
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sriram Yennu — M.D. Anderson Cancer Center
- Study coordinator: Sriram Yennu, MD
- Email: syennu@mdanderson.org
- Phone: (713) 792-3938
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.