Trial Information
Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma
OBJECTIVES:
I. To assess the prevalence of esophageal pathology (any esophageal abnormality,
specifically: esophagitis, stricture/web, infections, neoplasms) as identified by
esophagoscopy in patients with HNCA before and 3 months following primary radiation and/or
chemotherapy.
II. To assess the changes in self-reported dysphagia symptoms as measured by the Eating
Assessment Tool.
OUTLINE:
Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of
radiation therapy and/or chemotherapy.
Inclusion Criteria
Inclusion
- Written informed consent must be obtained from all participants prior to beginning
therapy; participants should have the ability to understand and be willing to sign a
written informed consent document
- Primary diagnosis of head and neck carcinoma (oral, hypopharyngeal, laryngeal)
- Stage I-IV, undergoing treatment with radiation therapy +/- chemotherapy
Exclusion
- Medical history of esophageal dysfunction
- Pregnant women are not excluded from participation
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Abnormal endoscopic esophageal examination
Outcome Description:
Abnormal endoscopic esophageal examination, as defined by presence of: stricture, web, ring, erosive esophagitis, fungal esophagitis, viral esophagitis, Barrett's metaplasia, neoplasm, or other.
Safety Issue:
No
Principal Investigator
Catherine Rees
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CCCWFU 60110
NCT ID:
NCT01164566
Start Date:
December 2010
Completion Date:
March 2012
Related Keywords:
- Stage I Adenoid Cystic Carcinoma of the Oral Cavity
- Stage I Mucoepidermoid Carcinoma of the Oral Cavity
- Stage I Squamous Cell Carcinoma of the Hypopharynx
- Stage I Squamous Cell Carcinoma of the Larynx
- Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage I Verrucous Carcinoma of the Larynx
- Stage I Verrucous Carcinoma of the Oral Cavity
- Stage II Adenoid Cystic Carcinoma of the Oral Cavity
- Stage II Mucoepidermoid Carcinoma of the Oral Cavity
- Stage II Squamous Cell Carcinoma of the Hypopharynx
- Stage II Squamous Cell Carcinoma of the Larynx
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Verrucous Carcinoma of the Larynx
- Stage II Verrucous Carcinoma of the Oral Cavity
- Stage III Adenoid Cystic Carcinoma of the Oral Cavity
- Stage III Mucoepidermoid Carcinoma of the Oral Cavity
- Stage III Squamous Cell Carcinoma of the Hypopharynx
- Stage III Squamous Cell Carcinoma of the Larynx
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Verrucous Carcinoma of the Larynx
- Stage III Verrucous Carcinoma of the Oral Cavity
- Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Larynx
- Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IV Verrucous Carcinoma of the Larynx
- Stage IV Verrucous Carcinoma of the Oral Cavity
- Carcinoma
- Carcinoma, Squamous Cell
- Carcinoma, Adenoid Cystic
- Head and Neck Neoplasms
- Laryngeal Diseases
- Carcinoma, Mucoepidermoid
- Carcinoma, Verrucous
- Hypopharyngeal Neoplasms
- Laryngeal Neoplasms
Name | Location |
Wake Forest University Health Sciences |
Winston-Salem, North Carolina 27157 |