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Understanding Oral Cancer Pain

This study aims to understand how Schwann cells (cells that support nerve fibers) contribute to pain in people with oral cancer, specifically squamous cell carcinoma. Researchers will compare how sensitive to pressure and stretch people with oral cancer are, compared to healthy volunteers. They will use a digital pressure algometer to measure pressure sensitivity on the tongue. The study will include 40 oral cancer patients and 40 healthy volunteers, all at least 18 years old and in good general health. The main goal is to measure pressure and stretch sensitivity at the beginning of the study. The study is currently unclear about its recruitment status.

Study design
This is a prospective study comparing pressure and stretch sensitivity between 40 oral cancer patients and 40 healthy volunteers.
What's involved
You would undergo pressure and stretch sensitivity testing on your tongue (if healthy) or at the cancer site (if you have oral cancer).
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07095608

Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain

Recruiting
NAAges 18+InterventionalBasic science
New York University
~80 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:Pressure and stretch sensitivity testing

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pressure sensitivity
Measured over Baseline
+1 more outcome measured

Conditions

Oral Cancer
Squamous Cell Carcinoma

Explore related trials

Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Brian L Schmidt, DDS · PRINCIPAL_INVESTIGATOR · NYU College of Dentistry

Who to contact

Yatendra Mulpuri, PhD
[email protected]
424-230-4222
Email the study team

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Eligibility criteria

Inclusion

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
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

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.
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.

What this trial measures

  • Pressure sensitivityBaseline

    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 sensitivityBaseline

    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.