Central Pain Syndrome in Survivors of Head and Neck Cancer

August 23, 2022 updated by: Dianne Lou, Vanderbilt-Ingram Cancer Center

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Response to Pain
Brain's response to pain using magnetic resonance imaging (MRI)
Delivers pressure to thumbnail for five seconds at a time
Scan of brain using Magnetic resonance imaging
Administration of questionnaires via computer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain
Time Frame: Approximately 8 weeks
MRI scan of brain to measure response to stimulated pressure to thumbnail
Approximately 8 weeks
Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype
Time Frame: Approximately 8 weeks
MRI scan of brain to measure response to stimulated pressure to thumbnail
Approximately 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dianne Lou, MD, PhD, Vanderbilt Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

July 21, 2022

Study Completion (Actual)

July 21, 2022

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC HN 1982

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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