Neuropathic Pain in Head and Neck Cancer

Trial Title: Neuropathic Pain in Head and Neck Cancer

NCT ID: NCT01846286

Condition: 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

Overall status: Unknown status

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Behavioral
Intervention name: Questionnaires
Description: Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete
Arm group label: Newly Diagnosed HNC

Other name: Surveys

Intervention type: Other
Intervention name: Quantitative Sensory Testing
Description: 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.
Arm group label: Newly Diagnosed HNC

Other name: QST

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 (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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. 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. 2. 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. 3. 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Lyndon B. Johnson General Hospital (LBJ)

Address:
City: Houston
Zip: 77026
Country: United States

Facility:
Name: University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Start date: October 15, 2012

Completion date: December 31, 2022

Lead sponsor:
Agency: M.D. Anderson Cancer Center
Agency class: Other

Collaborator:
Agency: National Institute of Dental and Craniofacial Research (NIDCR)
Agency class: NIH

Source: M.D. Anderson Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01846286
http://www.mdanderson.org