Clinical trial · Observational
Neuropathic Pain in Head and Neck Cancer
Molecular Epidemiology of Neuropathic Pain in Head and Neck Cancer
NCT01846286CI-TRIAL-00058724unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this research study is to learn more about chronic pain associated with cancer treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quantitative Sensory Testing | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Newly Diagnosed HNC
- description
- 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.
- interventionNames
- Behavioral: Questionnaires
- Other: Quantitative Sensory Testing
Primary outcomes (1)
- measure
- Genome-wide analyses on Participants with squamous cell carcinoma of the head and neck
- timeFrame
- 5 years
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.