Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DE022891 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cielito C. Reyes-Gibby, MSN, DRPH | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson General Hospital (LBJ) | Houston | Texas | 77026 | United States | ||
| University of Texas MD Anderson Cancer Center |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009437 | Neuralgia |
| D059787 | Acute Pain |
| D000377 | Agnosia |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood specimen
| Quantitative Sensory Testing | Other | 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. |
|
|
| Houston |
| Texas |
| 77030 |
| United States |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |