Central Pain Syndrome in Survivors of Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04128267
• Other study ID #: VICC HN 1982
• Status: Terminated
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: July 21, 2022

Study information

• Verified date: August 2022
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: July 21, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• IPC-1000
Delivers pressure to thumbnail for five seconds at a time
• Magnetic resonance imaging
Scan of brain using Magnetic resonance imaging

Other:
• Correlative Studies
Administration of questionnaires via computer

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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