Reviewing the epidemiology of head and neck cancer: definitions, trends and risk factors.
Mark Gormley, Grant Creaney, Andrew Schache...
https://pubmed.ncbi.nlm.nih.gov/36369568Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07095608
Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
Led by New York University · Updated on 2025-11-21
80
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
New York University
Lead Sponsor
N
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborating Sponsor
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
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
AI-Screening
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1
2
3
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)
Trial Site Locations
Total: 1 location
1
NYU College of Dentistry
New York, New York, United States, 10010
Actively Recruiting
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Research Team
Y
Yatendra Mulpuri, PhD
M
Mariana Bucovsky, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Published Research Related To This Trial
Biologic mechanisms of oral cancer pain and implications for clinical therapy.
C T Viet, B L Schmidt
https://pubmed.ncbi.nlm.nih.gov/21972258PIEZO2 mediates injury-induced tactile pain in mice and humans.
Marcin Szczot, Jaquette Liljencrantz, Nima Ghitani...
https://pubmed.ncbi.nlm.nih.gov/30305456The puzzle of TRPV4 channelopathies.
Bernd Nilius, Thomas Voets
https://pubmed.ncbi.nlm.nih.gov/23306656Increased keratinocyte activity and PIEZO1 signaling contribute to paclitaxel-induced mechanical hypersensitivity.
Alexander R Mikesell, Elena Isaeva, Marie L Schulte...
https://pubmed.ncbi.nlm.nih.gov/39661703Impaired pressure sensation in mice lacking TRPV4.
Makoto Suzuki, Atsuko Mizuno, Kunihiko Kodaira...
https://pubmed.ncbi.nlm.nih.gov/12692122TRPV4 activation in Schwann cells mediates mechanically induced pain of oral cancer.
Yatendra Mulpuri, Nguyen H Tu, Kenji Inoue...
https://pubmed.ncbi.nlm.nih.gov/40144515Reciprocal interactions between cancer and Schwann cells contribute to oral cancer progression and pain.
Elizabeth Salvo, Prakaimuk Saraithong, Jared G Curtin...
https://pubmed.ncbi.nlm.nih.gov/30815600Clinical Pharmacokinetics, Safety, and Tolerability of a Novel, First-in-Class TRPV4 Ion Channel Inhibitor, GSK2798745, in Healthy and Heart Failure Subjects.
Navin Goyal, Pete Skrdla, Rosemary Schroyer...
https://pubmed.ncbi.nlm.nih.gov/30637626