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Neuropathic Pain in Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms - Neuralgia
Conditions: Keywords
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
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Questionnaires
Type: Behavioral
Name: Quantitative Sensory Testing
Type: Other
Overall Status
Recruiting
Summary
The goal of this research study is to learn more about chronic pain associated with cancer treatment.
Detailed Description
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.
Additional Information:
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.
- 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.
Additional Information:
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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, researchers will only use cases who were:
- Newly diagnosed, untreated, histopathologically confirmed squamous cell carcinoma of the oral cavity, pharynx, or larynx
- No previous cancers
- Age 18 years or older
- white Caucasian.
Aim 2:
- Newly diagnosed patients (have not had any prior cancer treatment) with loco-regional squamous cell carcinoma of the head and neck
- Will receive cancer treatment at MDACC
- Are 18 years or older
- English or Spanish speaking
- Able to understand the description of the study and give written informed consent
- Will state that they will receive follow-up at MD Anderson post-treatment
- Self-reported Caucasian White 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. Thus, researchers focus on white caucasians in this particular study.
Aim 3: Patients included in aims 1 and 2.
Exclusion Criteria:
Aim 2:
- Patients with distant metastasis (Stage IVC)
- Patients participating in clinical trials/ investigational drugs for pain control. Aim 1 (discovery phase) and Aim 3 will use existing data.
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, researchers will only use cases who were:
- Newly diagnosed, untreated, histopathologically confirmed squamous cell carcinoma of the oral cavity, pharynx, or larynx
- No previous cancers
- Age 18 years or older
- white Caucasian.
Aim 2:
- Newly diagnosed patients (have not had any prior cancer treatment) with loco-regional squamous cell carcinoma of the head and neck
- Will receive cancer treatment at MDACC
- Are 18 years or older
- English or Spanish speaking
- Able to understand the description of the study and give written informed consent
- Will state that they will receive follow-up at MD Anderson post-treatment
- Self-reported Caucasian White 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. Thus, researchers focus on white caucasians in this particular study.
Aim 3: Patients included in aims 1 and 2.
Exclusion Criteria:
Aim 2:
- Patients with distant metastasis (Stage IVC)
- Patients participating in clinical trials/ investigational drugs for pain control. Aim 1 (discovery phase) and Aim 3 will use existing data.
Locations
Lyndon B. Johnson General Hospital (LBJ)
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Status: Recruiting
Houston, Texas, United States
Status: Recruiting
Start Date
October 2012
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page