Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Abnormal endoscopic esophageal examination
Study Overview
Brief Summary
Brief Summary:
RATIONALE: Comparing results of diagnostic procedures, such as esophagoscopy, done before and after radiation therapy and/or chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying esophagoscopy in evaluating treatment in patients with stage I-IV head and neck cancer who are undergoing radiation therapy and/or chemotherapy.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.
Intervention: endoscopic procedure (Procedure)
Arm I
Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.
Intervention: questionnaire administration (Other)
Outcomes
Primary Outcomes
Abnormal endoscopic esophageal examination
Time Frame: 3 months following completion of radiation therapy
Abnormal endoscopic esophageal examination, as defined by presence of: stricture, web, ring, erosive esophagitis, fungal esophagitis, viral esophagitis, Barrett's metaplasia, neoplasm, or other.
Secondary Outcomes
- Severity of self-rated swallowing dysfunction(3 months following completion of radiation therapy)