Neuropathic Pain in Head and Neck Cancer

May 23, 2022 updated by: M.D. Anderson Cancer Center

Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

838

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77026
        • Lyndon B. Johnson General Hospital (LBJ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

For AIM 1: Squamous cell carcinoma of the head and neck patients for whom genome-wide (730,525 SNPs) and pain data are available; AIM 2: Newly diagnosed and previously untreated patients with locoregional (excludes Stage IVc) squamous cell carcinoma of the head and neck recruited at the Head and Neck Center at MD Anderson; AIM 3: Populations from AIM 1 & 2.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly Diagnosed HNC
For AIM 2 and AIM3, Newly diagnosed and previously untreated patients with locoregional squamous cell carcinoma of the head and neck recruited at MD Anderson: Pain assessed at baseline, weekly during treatment, and during clinic visits (every 6-8 weeks) for a period of 3 months after treatment. Quantitative sensory testing performed at baseline and at 3 months from completion of treatment to determine nociceptive versus neuropathic component.
Behavioral: Questionnaires
Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete
Other Names:
  • Surveys
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.
Other Names:
  • QST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genome-wide analyses on Participants with squamous cell carcinoma of the head and neck
Time Frame: 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessed Pain Severity (mean pain)
Time Frame: Baseline to 3 months post treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Study Chair: Cielito C. Reyes-Gibby, MSN, DRPH, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2012

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0642
  • 1R01DE022891 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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