Neuropathic Pain in Head and Neck Cancer
Head and Neck Cancer
Other: Quantitative Sensory Testing
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer|
- Genome-wide analyses on Participants with squamous cell carcinoma of the head and neck [ Time Frame: 5 years ] [ Designated as safety issue: No ]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).
- Assessed Pain Severity (mean pain) [ Time Frame: Baseline to 3 months post treatment ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
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.
Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete
Other Name: SurveysOther: 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 Name: QST
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 (about 3 months later):
- 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.
- You will have sensory testing. These tests will measure your 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 you are more likely to have chronic pain.
During already scheduled clinic visits, about every 6-8 weeks, 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 6-12 months.
All of the tests and procedures described above will be scheduled for you to complete during your regularly scheduled clinic visits. Any information that is collected about your symptoms will be used for the purposes of this research study only. If you are having any severe and/or intolerable symptoms, you should contact the study doctor or study nurse right away.
This is an investigational study. Up to 1200 will take part at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846286
|Contact: Cielito C. Reyes-Gibby, MSN, DRPH||713-792-1816|
|United States, Texas|
|Lyndon B. Johnson General Hospital (LBJ)||Recruiting|
|Houston, Texas, United States, 77026|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Chair:||Cielito C. Reyes-Gibby, MSN, DRPH||M.D. Anderson Cancer Center|