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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stage I Adenoid Cystic Carcinoma of the Oral Cavity, Stage I Mucoepidermoid Carcinoma of the Oral Cavity, Stage I Squamous Cell Carcinoma of the Hypopharynx, Stage I Squamous Cell Carcinoma of the Larynx, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Verrucous Carcinoma of the Larynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Adenoid Cystic Carcinoma of the Oral Cavity, Stage II Mucoepidermoid Carcinoma of the Oral Cavity, Stage II Squamous Cell Carcinoma of the Hypopharynx, Stage II Squamous Cell Carcinoma of the Larynx, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Verrucous Carcinoma of the Larynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Adenoid Cystic Carcinoma of the Oral Cavity, Stage III Mucoepidermoid Carcinoma of the Oral Cavity, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, 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 Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Mucoepidermoid Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity

Intervention / Treatment
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* Procedure: endoscopic procedure
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy. | Procedure: endoscopic procedure<br> <br> * Other names: endoscopy;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months following completion of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of self-rated swallowing dysfunction | Severity of self-rated swallowing dysfunction, as rated with the Eating Assessment Tool (0-40) | 3 months following completion of radiation therapy |