Clinical trial NCT04128267: Central Pain Syndrome in Survivors of Head and Neck Cancer
Official title: Characterization of Central Pain Syndrome in Survivors of Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-16
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain
timeFrame: Approximately 8 weeks
measure: Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype
timeFrame: Approximately 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Dianne Lou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: