Neuropathic Pain in Head and Neck Cancer

NCT01846286 | Unknown

• 2 other identifiers: 2012-06421R01DE022891
• Study Type: observational
• Target: 838
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this research study is to learn more about chronic pain associated with cancer treatment.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Assessed Pain Severity (mean pain)

  Baseline to 3 months post treatment

Study Arms (1)

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.

Behavioral: Questionnaires; Other: Quantitative Sensory Testing

Interventions

Questionnaires BEHAVIORAL

Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete

Also known as: Surveys

Newly Diagnosed HNC

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.

Also known as: QST

Newly Diagnosed HNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.
• Aim 3: Patients included in aims 1 and 2.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (2)

Lyndon B. Johnson General Hospital (LBJ)

Houston, Texas, 77026, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen

MeSH Terms

Conditions

Head and Neck Neoplasms; Neuralgia; Acute Pain; Agnosia; Squamous Cell Carcinoma of Head and Neck; Chronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cielito C. Reyes-Gibby, MSN, DRPH

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: October 15, 2012
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

US (2)