Dissecting the Heterogeneity of Oral Cancer Pain

NCT05024383 | Unknown

• 1 other identifier: i21-00964
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Mechanical Sensitivity

  Pain will be evaluated using verbal feedback from participants for mechanical sensitivity testing.

  Baseline visit

• Chemical Sensitivity

  Pain will be evaluated using a visual analogue scale for chemical sensitivity testing.

  Baseline visit

Interventions

Chemical sensitivity OTHER

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.

Mechanical sensitivity OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven squamous cell carcinoma (SCC) of the oral cavity that requires surgical resection
• Lesion is at least 1 cm in greatest surface dimension

You may not qualify if:

• History of prior surgical, chemotherapeutic, or radiation treatment for head and neck cancer
• Pregnancy or lactation
• In good general health as evidenced by medical history
• Clinically and/or histologically proven oral pre-cancer, oral cancer
• Pregnancy or lactation

Sponsors & Collaborators

• NYU College of Dentistry: lead

Study Sites (1)

New York University College of Dentistry

New York, New York, 10010, United States

RECRUITING

Related Publications (4)

• Schmidt BL, Hamamoto DT, Simone DA, Wilcox GL. Mechanism of cancer pain. Mol Interv. 2010 Jun;10(3):164-78. doi: 10.1124/mi.10.3.7.

  PMID: 20539035 BACKGROUND

• Schmidt BL. The neurobiology of cancer pain. Neuroscientist. 2014 Oct;20(5):546-62. doi: 10.1177/1073858414525828. Epub 2014 Mar 24.

  PMID: 24664352 BACKGROUND

• Yang F, Zheng J. Understand spiciness: mechanism of TRPV1 channel activation by capsaicin. Protein Cell. 2017 Mar;8(3):169-177. doi: 10.1007/s13238-016-0353-7. Epub 2017 Jan 2.

  PMID: 28044278 BACKGROUND

• Jordt SE, Bautista DM, Chuang HH, McKemy DD, Zygmunt PM, Hogestatt ED, Meng ID, Julius D. Mustard oils and cannabinoids excite sensory nerve fibres through the TRP channel ANKTM1. Nature. 2004 Jan 15;427(6971):260-5. doi: 10.1038/nature02282. Epub 2004 Jan 7.

  PMID: 14712238 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Brian Schmidt, MD, DDS, PhD

CONTACT

212-995-4843; bls322@nyu.edu

Caroline Sawicki, DDS, PhD

CONTACT

212-995-4843; cs6135@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Bluestone Center for Clinical Research

Model Details: Single arm study design with group comparisons

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: September 30, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)