Neuropathic Pain in Head and Neck Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Migraine Headaches
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/6/2018
Start Date:October 2012
End Date:October 2019
Contact:Cielito C. Reyes-Gibby, MSN, DRPH
Phone:713-792-1816

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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.

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.

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.
We found this trial at
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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