Neuropathic Pain in Head and Neck Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01846286
First received: May 1, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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

AIM 1. To perform 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). Hypothesis 1: Potentially novel genetic variants that may also serve as therapeutic targets for pain will be identified using a genome-wide SNP scan.

AIM 2. To establish a cohort of head and neck cancer patients and determine the independent influence of cancer treatment, behavioral, epidemiological, biological, and clinical factors in predicting the development of chronic pain (neuropathic/nociceptive) in these participants. Hypothesis 2: The development of chronic pain will vary by cancer treatment, behavioral, epidemiological, and clinical factors.

AIM 3. To perform exploratory gene-gene and gene-treatment (type of cancer treatment) interaction analyses that will help identify individuals at highest risk for the development of chronic pain (neuropathic versus nociceptive) on the basis of their genetic risk profiles and treatment. Researchers will use a total of aim 1 and 2 study populations.


Condition Intervention
Head and Neck Cancer
Behavioral: Questionnaires
Other: Quantitative Sensory Testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Genome-wide analyses on Participants with squamous cell carcinoma of the head and neck [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Assessed Pain Severity (mean pain) [ Time Frame: Baseline to 3 months post treatment ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood specimen


Estimated Enrollment: 4100
Study Start Date: October 2012
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete
Other Name: Surveys
Other: Quantitative Sensory Testing
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.
Other Name: QST

Detailed Description:

Participants will complete the following tests and procedures at the beginning and at end of the study (about 3 months later):

  • 5 questionnaires about any pain and other symptoms, general well-being, drugs that may be taken, and personal information, such as age. The questionnaires will take about 25-50 minutes to complete.
  • Sensory testing will 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.
  • Blood (about 1 teaspoon) will be drawn to learn if participants are more likely to have chronic pain.

During already scheduled clinic visits, about every 6-8 weeks, participants will complete a questionnaire about pain. This questionnaire will take about 5-10 minutes to complete.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846286

Contacts
Contact: Cielito C. Reyes-Gibby, MSN, DRPH 713-792-1816

Locations
United States, Texas
The University of Texas (UT) MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Cielito C. Reyes-Gibby, MSN, DRPH UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01846286     History of Changes
Other Study ID Numbers: 2012-0642, 1R01DE022891
Study First Received: May 1, 2013
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Headache
Neuralgia
Neoplasms by Site
Neoplasms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 19, 2014