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

Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01164566
Enrollment
6
Registered
2010-07-16
Start date
2010-12-31
Completion date
2012-03-31
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERquestionnaire administration

Ancillary studies

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Abnormal endoscopic esophageal examination3 months following completion of radiation therapyAbnormal endoscopic esophageal examination, as defined by presence of: stricture, web, ring, erosive esophagitis, fungal esophagitis, viral esophagitis, Barrett's metaplasia, neoplasm, or other.

Secondary

MeasureTime frameDescription
Severity of self-rated swallowing dysfunction3 months following completion of radiation therapySeverity of self-rated swallowing dysfunction, as rated with the Eating Assessment Tool (0-40)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026