Status:
TERMINATED
Central Pain Syndrome in Survivors of Head and Neck Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
21+ years
Phase:
NA
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.
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. *...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04128267
Start Date
November 4 2019
End Date
July 21 2022
Last Update
September 19 2022
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232