Head and Neck Cancer
Conditions
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.
Interventions
DEVICEIPC-1000
Delivers pressure to thumbnail for five seconds at a time
DEVICEMagnetic resonance imaging
Scan of brain using Magnetic resonance imaging
OTHERCorrelative Studies
Administration of questionnaires via computer
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain | Approximately 8 weeks | MRI scan of brain to measure response to stimulated pressure to thumbnail |
| Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype | Approximately 8 weeks | MRI scan of brain to measure response to stimulated pressure to thumbnail |
Countries
United States
Participant flow
Recruitment details
This study enrolled participants at Vanderbilt University Medical Center from November 4, 2019 to July 21, 2022. The study stopped early due to low accrual and technical issues with equipment.
Participants by arm
| Arm | Count |
|---|---|
| Response to Pain Brain's response to pain using magnetic resonance imaging (MRI)
IPC-1000: Delivers pressure to thumbnail for five seconds at a time
Magnetic resonance imaging: Scan of brain using Magnetic resonance imaging
Correlative Studies: Administration of questionnaires via computer | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Disease progression | 1 |
| Overall Study | Participant failed to respond to multiple attempts to contact | 2 |
| Overall Study | Participant had other medical issues | 4 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Response to Pain |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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
Time frame: Approximately 8 weeks
Population: Data were not collected due to the technical issues.
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
Time frame: Approximately 8 weeks
Population: Data were not collected due to the technical issues.