An interventional study of Pressure and stretch sensitivity testing in Oral Cancer and Squamous Cell Carcinoma, sponsored by New York University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by New York University · Not applicable, Interventional, and Basic science
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.
Oral cancer, particularly squamous cell carcinoma (SCC), represents nearly 90% of all head and neck cancers. Most patients with oral cancer experience functional pain caused by pressure at the cancer site, along with discomfort from stretching during activities like talking, drinking, and swallowing. However, the intensity and nature of this pain can vary significantly among individual patients. Currently, there are no effective treatments available to relieve pain associated with oral cancer.
The current hypothesis regarding the cause of oral cancer pain suggests that oral cancers release pain mediators that sensitize and activate receptors on sensory nerves associated with cancer. Mechanosensitive ion channels, such as TRPV4, PIEZO1, and PIEZO2, are activated by pressure and stretch, and have been implicated in pathological pain. Preclinical studies show that mice lacking TRPV4 have impaired pressure sensation, and inhibiting TRPV4 in models of oral cancer reduces mechanical pain. TRPV4 is expressed in various cell types, including epithelial cells, fibroblasts, neurons, and Schwann cells, which are the glial cells that ensheathe the axons of sensory neurons. Cancer cells and Schwann cells interact reciprocally, promoting cancer growth and pain. Preliminary data indicate that Schwann cells isolated from the trigeminal nerve fibers innervating the cancers of oral cancer patients express functional TRPV4. In human Schwann cells, the activation of TRPV4 mediates mechanosensitivity. A TRPV4 inhibitor currently in clinical trials has been well-tolerated by patients and has demonstrated a good safety profile. A better understanding of TRPV4's role in oral cancer pain holds significant promise for the development of TRPV4 antagonists as new analgesics for alleviating pain in oral cancer patients.
There is a lack of published data regarding the effects of pressure and stretch on pain phenotypes in patients with oral cancers. This gap significantly hinders our understanding of the mechanisms underlying oral cancer pain. By quantitatively assessing the pressure and stretch sensitivities experienced by these patients, the investigators can gain valuable insights into the origins of their pain. In this proposal, the investigators hypothesize that the quality of pain experienced by oral cancer patients is influenced by the activation levels of mechanosensitive ion channels at the site of the cancer. The investigators will conduct sensitivity tests for pressure and stretch on oral cancer patients and compare the patients' sensitivities with those of healthy subjects. Furthermore, the investigators will evaluate the correlation between pressure and stretch sensitivity scores in oral cancer patients.
The investigators propose that the degree of pressure and stretch sensitivities experienced by oral cancer patients is quantifiable and depends on the functional expression of TRPV4 on Schwann cells.
377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.
This study's planned enrollment of 80 is above the median of 65 across 265 interventional studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →New York University is the lead sponsor of 120 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For healthy subjects to be eligible to participate in this study, an individual must meet all of the following criteria:
For oral cancer patients to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
Healthy subjects who meet any of the following criteria will be excluded from participation in this study:
Oral cancer patients who meet any of the following criteria will be excluded from participation in this 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
Oral cancer patients will be tested for pressure and stretch sensitivity. Pressure sensitivity will be evaluated with a digital pressure algometer by applying the probe tip to the site of cancer in oral cancer patients. Stretch sensitivity will be evaluated with visual analog scale recording of pain scores associated with tongue range of motions in oral cancer patients.
Behavioral: Pressure and stretch sensitivity testing
Healthy subjects will be tested for pressure and stretch sensitivity. Pressure sensitivity will be evaluated with a digital pressure algometer by applying the probe tip to the tongues of healthy subjects. Stretch sensitivity will be evaluated with visual analog scale recording of pain scores associated with tongue range of motions in healthy subjects.
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.
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: Baseline
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: Baseline
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: Baseline
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New York University