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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma

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 Summary:

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.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: 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.


Original Primary Outcome: 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.


Current Secondary Outcome: Severity of self-rated swallowing dysfunction [ Time Frame: 3 months following completion of radiation therapy ]

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


Original Secondary Outcome: Severity of self-rated swallowing dysfunction

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


Information By: Wake Forest University Health Sciences

Dates:
Date Received: July 7, 2010
Date Started: December 2010
Date Completion:
Last Updated: April 4, 2017
Last Verified: April 2012