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Clinical Trials/NCT01164566
NCT01164566
Terminated
Not Applicable

Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma

Wake Forest University Health Sciences1 site in 1 country6 target enrollmentDecember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stage I Adenoid Cystic Carcinoma of the Oral Cavity
Sponsor
Wake Forest University Health Sciences
Enrollment
6
Locations
1
Primary Endpoint
Abnormal endoscopic esophageal examination
Status
Terminated
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
March 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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)

Study Sites (1)

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