Clinical trial NCT01846286: Neuropathic Pain in Head and Neck Cancer
Official title: Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2013-05-03
Enrollment: 838
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Genome-wide analyses on Participants with squamous cell carcinoma of the head and neck
timeFrame: 5 years
Secondary outcomes:
measure: Assessed Pain Severity (mean pain)
timeFrame: Baseline to 3 months post treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital (LBJ)
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Cielito C. Reyes-Gibby, MSN, DRPH
role: STUDY_CHAIR
References: