Neuropathic Pain in Head and Neck Cancer

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

Detailed Description
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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.

Official Title
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Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Questionnaires
* Other: Quantitative Sensory Testing


Participation Criteria
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Eligibility Criteria
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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, 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. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly Diagnosed HNC<br>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<br>* Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete<br>* Other names: Surveys;Other: Quantitative Sensory Testing<br>* 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.<br>* Other names: QST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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