Central Pain Syndrome in Survivors of Head and Neck Cancer

Study Overview
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Brief Summary
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This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.

Detailed Description
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Primary objectives: To correlate structural and functional MRI signature with one of three pain phenotypes in head and neck cancer survivors: 1) no pain, 2) central pain, and 3) nociceptive pain. To correlate the presence of chronic systemic symptoms with pain phenotype Exploratory objectives: - DNA, RNA, and plasma will be collected for genomic, transcriptomic, and proteomic studies. Results will be vertically integrated along with the results of clinical studies described within this protocol to identify targets for future correlative studies.

Official Title
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Characterization of Central Pain Syndrome in Survivors of Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Device: IPC-1000
* Device: Magnetic resonance imaging
* Other: Correlative Studies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically proven head and neck cancer Patients without a diagnosis of head and neck cancer (up to 10 patients, see below) We anticipate enrolling a total of 75 patients with a history of head and neck cancer who will complete all questionnaires and MRI scanning. We will also recruit up to 10 patients WITHOUT a diagnosis of head and neck cancer to facilitate optimization of the MRI scanning processes. This will allow us to address logistical issues, such as pressure stimulator setup and timing of each scan to be performed. Completed multi-modality therapy a minimum of 6 weeks prior to study entry. Willing and able to provide informed consent All participants must be at least 21 years of age Able to speak English Exclusion Criteria: Patients who are pregnant Patients who are unable to lie still Patients who are unable tolerate pressure stimulator Non-MRI compatible devices such as aneurysm clips, cardiac pacemakers or defibrillators, cochlear implants, hardware, or any other implants Iron-based tattoos, pieces of metal (bullet, BB, shrapnel) close to or in an important organ (such as the eye), or other non-MRI compatible metal in the body

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Response to Pain<br>Brain's response to pain using magnetic resonance imaging (MRI) | Device: IPC-1000<br>* Delivers pressure to thumbnail for five seconds at a time<br>Device: Magnetic resonance imaging<br>* Scan of brain using Magnetic resonance imaging<br>Other: Correlative Studies<br>* Administration of questionnaires via computer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain | MRI scan of brain to measure response to stimulated pressure to thumbnail | Approximately 8 weeks | 
| Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype | MRI scan of brain to measure response to stimulated pressure to thumbnail | Approximately 8 weeks |