Clinical trial · Interventional
Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
NCT07095608CI-TRIAL-00097658recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pressure and stretch sensitivity testing | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oral Cancer Subjects
- description
- 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.
- interventionNames
- Behavioral: Pressure and stretch sensitivity testing
- type
- ACTIVE_COMPARATOR
- label
- Healthy Subjects
- description
- 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.
- interventionNames
- Behavioral: Pressure and stretch sensitivity testing
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDGormley M, Creaney G, Schache A, Ingarfield K, Conway DI. Reviewing the epidemiology of head and neck cancer: definitions, trends and risk factors. Br Dent J. 2022 Nov;233(9):780-786. doi: 10.1038/s41415-022-5166-x. Epub 2022 Nov 11. PMID 36369568
- BACKGROUNDViet CT, Schmidt BL. Biologic mechanisms of oral cancer pain and implications for clinical therapy. J Dent Res. 2012 May;91(5):447-53. doi: 10.1177/0022034511424156. Epub 2011 Oct 4. PMID 21972258
- BACKGROUNDSzczot M, Liljencrantz J, Ghitani N, Barik A, Lam R, Thompson JH, Bharucha-Goebel D, Saade D, Necaise A, Donkervoort S, Foley AR, Gordon T, Case L, Bushnell MC, Bonnemann CG, Chesler AT. PIEZO2 mediates injury-induced tactile pain in mice and humans. Sci Transl Med. 2018 Oct 10;10(462):eaat9892. doi: 10.1126/scitranslmed.aat9892. PMID 30305456
- BACKGROUNDNilius B, Voets T. The puzzle of TRPV4 channelopathies. EMBO Rep. 2013 Feb;14(2):152-63. doi: 10.1038/embor.2012.219. Epub 2013 Jan 11. PMID 23306656
- BACKGROUNDMikesell AR, Isaeva E, Schulte ML, Menzel AD, Sriram A, Prahl MM, Shin SM, Sadler KE, Yu H, Stucky CL. Increased keratinocyte activity and PIEZO1 signaling contribute to paclitaxel-induced mechanical hypersensitivity. Sci Transl Med. 2024 Dec 11;16(777):eadn5629. doi: 10.1126/scitranslmed.adn5629. Epub 2024 Dec 11. PMID 39661703
- BACKGROUNDSuzuki M, Mizuno A, Kodaira K, Imai M. Impaired pressure sensation in mice lacking TRPV4. J Biol Chem. 2003 Jun 20;278(25):22664-8. doi: 10.1074/jbc.M302561200. Epub 2003 Apr 13. PMID 12692122
- BACKGROUNDMulpuri Y, Tu NH, Inoue K, Harden G, Nicholson SJ, Seenauth A, Huang Y, Escobar KG, Moayedi Y, Bunnett NW, Albertson DG, Schmidt BL. TRPV4 activation in Schwann cells mediates mechanically induced pain of oral cancer. Front Pain Res (Lausanne). 2025 Mar 12;6:1532885. doi: 10.3389/fpain.2025.1532885. eCollection 2025.