Head and Neck CancerNCT04128267
Central Pain Syndrome in Survivors of Head and Neck Cancer
A study testing IPC-1000, Magnetic resonance imaging and Correlative Studies in people with Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- IPC-1000, Magnetic resonance imaging and Correlative Studies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 21 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- IPC-1000, Magnetic resonance imaging, Correlative Studies
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPC-1000Device
Delivers pressure to thumbnail for five seconds at a time
Magnetic resonance imagingDevice
Scan of brain using Magnetic resonance imaging
Correlative StudiesOther
Administration of questionnaires via computer
| Study group | Role | What they receive |
|---|---|---|
| Response to Pain | Experimental | Brain's response to pain using magnetic resonance imaging (MRI) Receives: Device: IPC-1000; Device: Magnetic resonance imaging; Other: Correlative Studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 8 weeks
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
Measured: Approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start4 Nov 2019
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Why it stopped: Recruitment/accrual impacted by COVID and technical issues with equipment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Dianne Lou, Vanderbilt-Ingram Cancer Center
- Investigators
- Dianne Lou, MD, PhD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128267
- Sponsor's protocol ID
- VICC HN 1982
- Status last verified
- Aug 2022
- First submitted
- 14 Oct 2019
- Last updated
- 19 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Central Pain Syndrome in Survivors of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04128267
- Acronym / sponsor ID
- VICC HN 1982
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment/accrual impacted by COVID and technical issues with equipment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 19 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Response to Pain | Experimental | Device: IPC-1000, Device: Magnetic resonance imaging, Other: Correlative StudiesBrain's response to pain using magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically proven head and neck cancer
- Patients without a diagnosis of head and neck cancer (up to 10 patients, see below)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPC-1000Delivers pressure to thumbnail for five seconds at a time | Device | Response to Pain |
| Magnetic resonance imagingScan of brain using Magnetic resonance imaging | Device | Response to Pain |
| Correlative StudiesAdministration of questionnaires via computer | Other | Response to Pain |
Primary outcome
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dianne Lou, MD, PhD principal investigator
Vanderbilt Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPC-1000, Magnetic resonance imaging and Correlative Studies in people with Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.