Have you or your loved ones been diagnosed with head and neck cancer?

You may be eligible to participate in a head and neck cancer clinical trial.

Have you or your loved ones been diagnosed with head and neck cancer? You may be eligible to participate in a head and neck cancer clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Head and Neck Cancer Clinical Trial

NCT01846286 | Observational

Have you or your loved ones been diagnosed with head and neck cancer?

You may be eligible to participate in a head and neck cancer clinical trial.

Have you or your loved ones been diagnosed with head and neck cancer? You may be eligible to participate in a head and neck cancer clinical trial.

Active not recruiting

Male & Female

18 Years +

This study has recruited 838 Participants

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

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Details for the 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.

Brief Title

Neuropathic Pain in Head and Neck Cancer

Official Title

Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer

Brief Summary

The goal of this research study is to learn more about chronic pain associated with cancer <br /> 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.

Treatments and/or Procedures

Questionnaires

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

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Study Criteria

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.