MedTrace Logo

Dissecting the Heterogeneity of Oral Cancer Pain

NCT05024383 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-09-28

No results posted yet for this study

Summary

Oral squamous cell carcinoma (SCC) produces a higher prevalence and more severe pain than all other cancers. Orofacial pain is one of the most common initial symptoms of oral cancer and often leads to the diagnosis of oral cancer. However, the character, severity, and unique features of oral cancer widely differ between patients. There is currently no effective and lasting treatment available to alleviate suffering from oral cancer pain.

A significant obstacle to effectively treating cancer pain is that the relative contributions of nociceptive mediators and their mechanisms of action (i.e., responsible receptors) are largely unknown. There is, therefore, a critical need to define the neurobiologic mechanisms responsible for oral cancer pain. Without such information, the promise of non-opioid therapy for the treatment of oral cancer pain will remain unfulfilled.

The primary objective of this study is to define and quantify the phenotype of oral cancer pain in patients, by comparing mechano- and chemosensitivity in oral cancer patients with healthy subjects. Pain will be stimulated on the site of cancer in 40 oral cancer patients and on the tongue in 40 healthy volunteers utilizing chemical sensitivity and mechanical sensitivity tests.

Conditions

  • Oral Squamous Cell Carcinoma

Interventions

OTHER

Chemical sensitivity

Chemical sensitivity will be evaluated with paper taste strips embedded with varying concentrations of capsaicin solutions (activates TRPV1) and allyl isothiocyanate solutions (activates TRPA1) applied to the tongues of healthy subjects and site of cancer in oral cancer patients.

OTHER

Mechanical sensitivity

Mechanical sensitivity will be evaluated via von Frey filaments applied to the tongues of healthy subjects and and site of cancer in oral cancer patients.

Sponsors & Collaborators

  • NYU College of Dentistry

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024383 on ClinicalTrials.gov