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

Not Applicable

Terminated

• Conditions: Stage I Squamous Cell Carcinoma of the Larynx; Stage II Adenoid Cystic Carcinoma of the Oral Cavity; Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity; 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 Verrucous Carcinoma of the Larynx; Stage I Mucoepidermoid Carcinoma of the Oral Cavity; Stage II Mucoepidermoid Carcinoma of the Oral Cavity; Stage III Mucoepidermoid Carcinoma of the Oral Cavity
• Interventions: Procedure: endoscopic procedure; Other: questionnaire administration

• Registration Number: NCT01164566
• Lead Sponsor: Wake Forest University Health Sciences

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 Timeline

• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Study Start: 2010-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	endoscopic procedure	Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.
Arm I	questionnaire administration	Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.

Primary Outcome Measures

Name	Time	Method
Abnormal endoscopic esophageal examination	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 Outcome Measures

Name	Time	Method
Severity of self-rated swallowing dysfunction	3 months following completion of radiation therapy	Severity of self-rated swallowing dysfunction, as rated with the Eating Assessment Tool (0-40)

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States