NCT07095608 · New York University
Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
What this study is about
This is a forward-looking study involving human participants. Pressure and stretch sensitivity measures between taken by mouth cancer patients and healthy subjects will be compared. Pain stimulation will be conducted on the site of the cancer in 40 taken by mouth cancer patients, and on the tongue in 40 healthy volunteers, using pressure and stretch sensitivity tests.
View original scientific description
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.
Interventions
BEHAVIORAL
Pressure and stretch sensitivity testing
We 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.
Primary outcome measures
Pressure sensitivity
Time frame: Baseline
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.
Stretch sensitivity
Time frame: Baseline
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For healthy subjects to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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 For oral cancer patients to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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
- Biopsy-proven squamous cell carcinoma (SCC) of the oral cavity that requires surgical resection
- Lesion is at least 1 cm in greatest surface dimension
Exclusion criteria
- Healthy subjects who meet any of the following criteria will be excluded from participation in this study:
- 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. Oral cancer patients who meet any of the following criteria will be excluded from participation in this study:
- History of prior surgical, chemotherapeutic, or radiation treatment for head and neck cancer
- Pregnancy or lactation
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. For participants with impaired kidney function (chronic kidney/renal disease) who wish to participate in the proposed research study, consultation with their primary care provider will be done prior to enrollment to determine safety
Where
- New York, New York
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Nov 21, 2025 · Source of record for eligibility and locations