NCT04128267

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
2 months until next milestone

Results Posted

Study results publicly available

September 19, 2022

Completed
Last Updated

September 19, 2022

Status Verified

August 1, 2022

Enrollment Period

2.7 years

First QC Date

October 14, 2019

Results QC Date

July 28, 2022

Last Update Submit

August 23, 2022

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Approximately 8 weeks

Study Arms (1)

Response to Pain

EXPERIMENTAL

Brain's response to pain using magnetic resonance imaging (MRI)

Device: IPC-1000Device: Magnetic resonance imagingOther: Correlative Studies

Interventions

IPC-1000DEVICE

Delivers pressure to thumbnail for five seconds at a time

Response to Pain
Magnetic resonance imagingDEVICE

Scan of brain using Magnetic resonance imaging

Response to Pain
Correlative StudiesOTHER

Administration of questionnaires via computer

Response to Pain

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Teresa Melton
Organization
Vanderbilt-Ingram Cancer Center
teresa.melton@vumc.org
(615) 936-7423

Study Officials

  • Dianne Lou, MD, PhD

    Vanderbilt Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 16, 2019

Study Start

November 4, 2019

Primary Completion

July 21, 2022

Study Completion

July 21, 2022

Last Updated

September 19, 2022

Results First Posted

September 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)