Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNew York University
About this trial
This is a prospective study involving human participants. Pressure and stretch sensitivity measures between oral cancer patients and healthy subjects will be compared. Pain stimulation will be conducted on the site of the cancer in 40 oral cancer patients, and on the tongue in 40 healthy volunteers, using pressure and stretch sensitivity tests.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provide signed and dated informed consent form
Willing to comply with all study procedures and be available for the duration of the study
Male or female, at least 18 years of age
In good general health as evidenced by medical history
Disqualifiers
Clinically and/or histologically proven oral pre-cancer, oral cancer
Pregnancy or lactation (Female subjects of child-bearing potential will have a rapid urine pregnancy test)
Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
History of prior surgical, chemotherapeutic, or radiation treatment for head and neck cancer
Trial design
Design model
Parallel
Treatments tested in this trial
Pressure and stretch sensitivity testing
BehavioralWe will measure pressure sensitivity by applying gradual pressure (50 kPa/s) at the site of testing using a digital pressure algometer. In healthy subjects, we will perform these measurements on the lateral tongue on the left and the right side. In cancer patients, we will first test on the unaffected contralateral matched site and then at the site of the cancer. We will define pressure sensitivity as the mean of three threshold measurements. For measuring stretch sensitivity, we will use a visual analog scale (VAS) recording of pain scores associated with tongue stretching. Participants will be asked to perform tongue range of motions (ROM): protrusion, elevation, right and left lateralization, and rate sensitivity score on the VAS scale after holding the tongue in position for five seconds. We will define stretch sensitivity as the sum of VAS scores for protrusion, elevation, right and left lateralization.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Oral Cancer SubjectsExperimental treatment 1 intervention
Group B: Healthy SubjectsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pressure sensitivity
Pressure pain thresholds will be measured in kilopascals with a digital pressure algometer. The average of three measurements will be used to determine each threshold. Lower thresholds signify higher pain levels.
Time frame
Baseline2
Stretch sensitivity
Stretch sensitivity will be evaluated by assessing pain or discomfort associated with tongue range of motions (tongue protrusion, tongue elevation, right lateralization and left lateralization).To measure stretch sensitivity, visual analog scale (VAS) scores for participants' pain associated with tongue stretching will be recorded. Participants will perform tongue range of motions (ROM): protrusion, elevation, and right and left lateralization, and they will rate their sensitivity on the VAS scale after holding each position for five seconds. Subjects will also rate the quality of their pain. Stretch sensitivity will be defined as the sum of VAS scores for protrusion, elevation, and right and left lateralization. The VAS goes from 0-100, 0 representing no pain and 100 representing the most intense pain imaginable.
Time frame
BaselineSecondary outcomes
1
To determine whether patients with lower pressure pain thresholds report higher pain scores on the visual analog scale after tongue stretching.
Pressure pain thresholds will be measured in kilopascals with a digital pressure algometer. The average of three measurements will be used to determine each threshold. Lower thresholds signify higher pain levels. The tongue stretch questionnaire records the total VAS pain scores for lingual range of motion. Higher scores indicate more pain. The dependent variables of the pressure and stretch tests will be evaluated for a linear relationship.
Time frame
BaselineSponsors and contacts
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New York University
Lead sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Source ClinicalTrials.gov