NCT04128267

Central Pain Syndrome in Survivors of Head and Neck Cancer

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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. * 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-04
• Primary completion: 2022-07-21
• Completion: 2022-07-21
• First posted: 2019-10-16
• Last updated: 2022-09-19
• Results posted: 2022-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study