What is this study trying to find out about oral cancer pain?

This study is investigating how pressure and stretch sensitivity relate to pain in oral cancer patients. Researchers want to understand the role of the TRPV4 ion channel on Schwann cells in causing pain. This knowledge may help develop new pain treatments for oral cancer. The study is sponsored by New York University.

Who may be eligible for this oral cancer clinical trial?

Adults 18 years and older with biopsy-proven oral squamous cell carcinoma requiring surgery or healthy adults without oral cancer may be eligible. Both males and females can participate. Key factors include general good health and no prior head and neck cancer treatments. Please review eligibility criteria for more details.

Is there any cost to participate in this oral cancer clinical trial?

Study-related care, including testing and trial visits, is provided at no cost. However, personal travel expenses to and from the study sites may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

Healthy Volunteers

ID07095608

Studying How Schwann Cell TRPV4 Affects Pain in Oral Cancer Patients Comparing Pressure and Stretch Sensitivity Between Oral Cancer Patients and Healthy Adults

Led by New York University · Updated on 2025-11-21

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying oral cancer pain, focusing on squamous cell carcinoma SCC, which makes up nearly 90% of head and neck cancers. Many oral cancer patients experience pain caused by pressure and stretching at the cancer site, affecting activities like talking and swallowing. There is currently no effective treatment for this pain. The study aims to understand how specific ion channels, especially TRPV4 on Schwann cells, contribute to this pain by comparing oral cancer patients and healthy subjects. The study involves measuring pressure and stretch sensitivity using a digital pressure algometer and visual analog scale VAS pain scores. Oral cancer patients will have pressure sensitivity tested at the cancer site and stretch sensitivity assessed through tongue movements. Healthy volunteers will undergo similar tests on their tongues. The study will compare these sensitivity measures between the two groups to explore the role of TRPV4 in oral cancer pain. Participants will undergo pressure and stretch sensitivity tests, with pressure measured by applying gradual pressure and stretch evaluated by rating pain during specific tongue movements. Researchers will assess correlations between pressure pain thresholds and stretch pain scores. The study includes 40 oral cancer patients and 40 healthy volunteers, with ongoing monitoring of pain responses and safety. Participation is expected to last through baseline testing and assessments.

CONDITIONS

Brief Title

Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	People with Oral Cancer	Healthy Volunteers
What it is	Testing pressure and stretch pain sensitivity on the tongue of patients with oral squamous cell carcinoma before surgery.	Testing tongue pressure and stretch pain sensitivity in adults without oral cancer, serving as controls.
Role in the trial	Evaluates how oral cancer affects mechanical pain sensitivity prior to surgery.	Provides a reference baseline for mechanical pain sensitivity in people without oral disease.
Primary use	Assesses correlations between oral cancer, sensory nerve function, and mechanical pain to better understand oral cancer pain mechanisms.	Defines normal sensory thresholds using matched measurements for comparison with oral cancer patients.
How it is performed	Pressure sensitivity is measured with a digital algometer at the tongue cancer site and contralateral side; stretch sensitivity is tested through tongue movements with pain ratings recorded on a visual analog scale.	Pressure is tested at both sides of the lateral tongue and stretch sensitivity is rated after tongue movements, using the same procedure as the cancer group.
Evidence status	The role of Schwann cells and TRPV4 in oral cancer pain is supported by preclinical and early clinical findings, but pressure and stretch sensitivity measurements in this exact context are still being investigated.	Healthy control data provide baseline sensory thresholds. No disease or tissue injury is present in these subjects.
Important limitations	This is an experimental study with a small sample; test results may be influenced by individual differences in pain perception and by the specific stage or site of the cancer. The findings are not directly generalizable to treatment or pain management outcomes.	Healthy subject data do not represent the presence of oral cancer or surgical intervention, and individual sensitivity can vary for reasons unrelated to oral health.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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
For healthy subjects: In good general health as evidenced by medical history
For oral cancer patients: Biopsy-proven squamous cell carcinoma of the oral cavity requiring surgical resection
For oral cancer patients: Lesion at least 1 cm in greatest surface dimension

You will not qualify if you...

Healthy subjects with clinically or histologically proven oral pre-cancer or oral cancer
Pregnancy or lactation
Anything that would increase risk or prevent full compliance with or completion of the study
Oral cancer patients with prior surgical, chemotherapeutic, or radiation treatment for head and neck cancer
Participants with impaired kidney function must consult their primary care provider before enrollment

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Single session

Participants undergo pressure and stretch sensitivity testing to evaluate pain associated with oral cancer or to establish baseline sensitivity in healthy subjects.

1 visit (in-person)