Neuropathic Pain in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01846286
• Other study ID #: 2012-0642
• Secondary ID: 1R01DE022891
• Status: Active, not recruiting
• Start date: October 15, 2012
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this research study is to learn more about chronic pain associated with cancer treatment.

Description:

If you agree to take part in this study, you will complete the following tests and procedures at the beginning and at the end of the study (on clinic visits, typically around 3-6 months after completion of treatment):

°You will complete 5 questionnaires about any pain and other symptoms you may have had, your general well-being, drugs you may be taking, and personal information, such as your age. The questionnaires will take about 25-50 minutes to complete.

Every week during treatment period, you will complete a questionnaire about pain you may be having. This questionnaire will take about 5-10 minutes to complete.

Length of Study:

You will be on study for about 3-6 months after the last day of treatment.

This is an investigational study. Up to 1200 will take part at MD Anderson.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 838
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aim 1 Discovery Phase: The samples are from a large NIH-funded Genome-wide association study of squamous cell carcinoma of the head and neck (Shete; PI). A total of 2900 "case" patients and 1200 control patients were recruited for the study. In this study, we will only use cases who were: a) Newly diagnosed, untreated, histopathologically confirmed squamous cell carcinoma of the oral cavity, pharynx, or larynx; b) No previous cancers; c) Age 18 years or older; d) white Caucasian.

2. Aim 2: a) Newly diagnosed patients (have not had any prior cancer treatment) with loco-regional squamous cell carcinoma of the head and neck, b) Will receive cancer treatment at MDACC or at Ben Taub, c) Are 18 years or older, d) English or Spanish speaking; e) Able to understand the description of the study and give written informed consent; f) Will state that they will receive follow-up at MD Anderson post-treatment or at Ben Taub. This sample will also be included in the Validation Phase of Aim 1. We note that population stratification, i.e., the presence of a systematic difference in allele frequencies between subpopulations in a population possibly due to different ancestry, is an issue for genetic association studies.

3. Aim 3: Patients included in aims 1 and 2.

Exclusion Criteria:

1) Exclusion for Aim 2: a) Patients with distant metastasis (Stage IVC); b. Patients participating in clinical trials/ investigational drugs for pain control. Aim 1 (discovery phase) and Aim 3 will use existing data.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Neuralgia

Intervention

Behavioral:
• Questionnaires
Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete

Other:
• Quantitative Sensory Testing
Tests measure sensitivity to touch, coolness, warmth, hot/cold feeling, and pin pricks. The sensory tests will take about 30 minutes to 1 hour to complete.

Locations

Country	Name	City	State
United States	Lyndon B. Johnson General Hospital (LBJ)	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genome-wide analyses on Participants with squamous cell carcinoma of the head and neck	Genome-wide analyses, 730,525 Single Nucleotide Polymorphisms (SNPs), on participants with squamous cell carcinoma of the head and neck in order to identify potentially novel gene variants associated with the development of chronic pain (neuropathic versus nociceptive).	5 years
Secondary	Assessed Pain Severity (mean pain)	Pain Severity determined using 0-10 numeric rating scale (0= 'no pain' and 10='worst pain imaginable'). Pain assessed at baseline (start of the study), weekly during treatment, and during clinic visits (every 6-8 weeks) for a period of 3 months after treatment.	Baseline to 3 months post treatment

External Links

•   University of Texas MD Anderson Cancer Center Website