Central Pain Syndrome in Survivors of Head and Neck Cancer

Vanderbilt University Medical Center

Status

Terminated

Conditions

Head and Neck Cancer

Treatments

Other: Correlative Studies

Device: Magnetic resonance imaging

Device: IPC-1000

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04128267

VICC HN 1982

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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