How TRPV4 in Schwann cells contributes to oral cancer pain
Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
This project will test whether pressure- and stretch-triggered pain at oral cancer sites differs from the healthy tongue and whether TRPV4 in Schwann cells contributes to that pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | New York University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07095608 on ClinicalTrials.gov |
What this trial studies
This prospective protocol will enroll 40 adults with biopsy-proven oral squamous cell carcinoma and 40 healthy adult volunteers. Investigators will perform standardized pressure and stretch sensitivity tests at the tumor site in patients and on the tongue in controls, recording pain thresholds and intensity. When available, surgical tissue or isolated Schwann cells will be analyzed for TRPV4 expression to correlate molecular findings with sensory measures. The approach aims to link mechanosensitivity in patients to TRPV4 activity in Schwann cells as a possible mechanism driving oral cancer pain.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with biopsy-proven oral squamous cell carcinoma at least 1 cm in size who are scheduled for surgical resection, and healthy adult volunteers in good general health for the control group.
Not a fit: Patients without biopsy-proven oral SCC, those with lesions smaller than 1 cm, those not undergoing resection, or patients whose pain is not driven by mechanosensitive pathways are unlikely to benefit directly from this work.
Why it matters
Potential benefit: If successful, the findings could point to new pain treatments that target TRPV4 to reduce pressure- and stretch-related oral cancer pain.
How similar studies have performed: Preclinical animal studies show that TRPV4 inhibition reduces mechanical pain, but human data linking Schwann cell TRPV4 to oral cancer pain are limited, making this a relatively novel clinical translation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- NYU College of Dentistry — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Brian L Schmidt, DDS — NYU College of Dentistry
- Study coordinator: Yatendra Mulpuri, PhD
- Email: ym2891@nyu.edu
- Phone: 424-230-4222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.