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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

This study has been terminated.
(Inadequate Recruitment)
Sponsor:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01164566
First received: July 7, 2010
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
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
 Procedure: endoscopic procedure
Other: questionnaire administration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Abnormal endoscopic esophageal examination [ Designated as safety issue: No ]
    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:
  • Severity of self-rated swallowing dysfunction [ Designated as safety issue: No ]
    Severity of self-rated swallowing dysfunction, as rated with the Eating Assessment Tool (0-40)


Enrollment: 6
Study Start Date: December 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.
 Procedure: endoscopic procedure
Other Name: endoscopy
Other: questionnaire administration
Ancillary studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164566

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Catherine Rees Wake Forest University
  More Information

No publications provided

Responsible Party: Rees, Catherine, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01164566     History of Changes
Other Study ID Numbers: CCCWFU 60110, NCI-2010-01466
Study First Received: July 7, 2010
Last Updated: April 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenoid Cystic
Head and Neck Neoplasms
Laryngeal Diseases
Carcinoma, Mucoepidermoid
Carcinoma, Verrucous
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Adenocarcinoma
Neoplasms by Site
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neoplasms, Cystic, Mucinous, and Serous
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013