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Central Pain Syndrome in Survivors of Head and Neck Cancer

Not Applicable
Terminated
Conditions
Head and Neck Cancer
Interventions
Device: IPC-1000
Device: Magnetic resonance imaging
Other: Correlative Studies
Registration Number
NCT04128267
Lead Sponsor
Vanderbilt-Ingram Cancer Center
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.

* 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 & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
32
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Response to PainCorrelative StudiesBrain's response to pain using magnetic resonance imaging (MRI)
Response to PainIPC-1000Brain's response to pain using magnetic resonance imaging (MRI)
Response to PainMagnetic resonance imagingBrain's response to pain using magnetic resonance imaging (MRI)
Primary Outcome Measures
NameTimeMethod
Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain PhenotypeApproximately 8 weeks

MRI scan of brain to measure response to stimulated pressure to thumbnail

Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive PainApproximately 8 weeks

MRI scan of brain to measure response to stimulated pressure to thumbnail

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center

🇺🇸

Nashville, Tennessee, United States

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