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Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer

18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer

Participants will complete the following tests and procedures at the beginning and at end of
the study (about 3 months later):

- 5 questionnaires about any pain and other symptoms, general well-being, drugs that may
be taken, and personal information, such as age. The questionnaires will take about
25-50 minutes to complete.

- Sensory testing will 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.

- Blood (about 1 teaspoon) will be drawn to learn if participants are more likely to have
chronic pain.

During already scheduled clinic visits, about every 6-8 weeks, participants will complete a
questionnaire about pain. This questionnaire will take about 5-10 minutes to complete.

Inclusion Criteria:

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,
researchers will only use cases who were:

- Newly diagnosed, untreated, histopathologically confirmed squamous cell carcinoma of
the oral cavity, pharynx, or larynx

- No previous cancers

- Age 18 years or older

- white Caucasian.

Aim 2:

- Newly diagnosed patients (have not had any prior cancer treatment) with loco-regional
squamous cell carcinoma of the head and neck

- Will receive cancer treatment at MDACC

- Are 18 years or older

- English or Spanish speaking

- Able to understand the description of the study and give written informed consent

- Will state that they will receive follow-up at MD Anderson post-treatment

- Self-reported Caucasian White 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.
Thus, researchers focus on white caucasians in this particular study.

Aim 3: Patients included in aims 1 and 2.

Exclusion Criteria:

Aim 2:

- Patients with distant metastasis (Stage IVC)

- Patients participating in clinical trials/ investigational drugs for pain control.
Aim 1 (discovery phase) and Aim 3 will use existing data.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Genome-wide analyses on Participants with squamous cell carcinoma of the head and neck

Outcome Description:

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).

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Cielito C. Reyes-Gibby, MSN, DRPH

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Neuropathic Pain
  • Squamous cell cancer of the head and neck
  • acute pain
  • pain management
  • genome-wide analyses
  • Squamous cell carcinoma of the head and neck
  • chronic pain
  • neuropathic
  • locoregional squamous cell carcinoma of the head and neck
  • Head and Neck Neoplasms
  • Headache
  • Neuralgia



The University of Texas (UT) MD Anderson Cancer Center Houston, Texas  77030