Esophagoscopy in Evaluating Treatment in Patients With Stage I-IV Head and Neck Cancer Who Are Undergoing Radiation Therapy and/or Chemotherapy

Wake Forest University Health Sciences6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Stage I Adenoid Cystic Carcinoma of the Oral Cavity Stage I Mucoepidermoid Carcinoma of the Oral Cavity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Abnormal endoscopic esophageal examination

Abnormal endoscopic esophageal examination, as defined by presence of: stricture, web, ring, erosive esophagitis, fungal esophagitis, viral esophagitis, Barrett's metaplasia, neoplasm, or other.

Time frame: 3 months following completion of radiation therapy

Secondary Outcomes

Severity of self-rated swallowing dysfunction

Severity of self-rated swallowing dysfunction, as rated with the Eating Assessment Tool (0-40)