Central Pain Syndrome in Survivors of Head and Neck Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Response to Pain Brain's response to pain using magnetic resonance imaging (MRI) |
Device: IPC-1000
Delivers pressure to thumbnail for five seconds at a time
Device: Magnetic resonance imaging
Scan of brain using Magnetic resonance imaging
Other: Correlative Studies
Administration of questionnaires via computer
|
Outcome Measures
Primary Outcome Measures
- Magnetic resonance imaging (MRI) to correlate with one of three pain phenotypes 1) no pain, 2) central pain, 3) nociceptive pain [Approximately 8 weeks]
MRI scan of brain to measure response to stimulated pressure to thumbnail
- Magnetic resonance imaging (MRI) to correlate presence of chronic systemic symptoms with pain phenotype [Approximately 8 weeks]
MRI scan of brain to measure response to stimulated pressure to thumbnail
Eligibility Criteria
Criteria
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)
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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.
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Completed multi-modality therapy a minimum of 6 weeks prior to study entry.
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Willing and able to provide informed consent
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All participants must be at least 21 years of age
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Able to speak English
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Dianne Lou, MD, PhD, Vanderbilt Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- VICC HN 1982