Neuropathic Pain in Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT01846286|
Recruitment Status : Recruiting
First Posted : May 3, 2013
Last Update Posted : October 3, 2017
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Behavioral: Questionnaires Other: Quantitative Sensory Testing|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer|
|Actual Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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
- Genome-wide analyses on Participants with squamous cell carcinoma of the head and neck [ Time Frame: 5 years ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|