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NCT01164566 Clinical Trial

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

Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial

Official title:
Prospective Evaluation of Esophageal Pathology Treatment of Head and Neck Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01164566
Other study ID # IRB00012541
Secondary ID NCI-2010-01466CC
Status Terminated
Phase N/A
First received
Last updated
Start date December 2010
Est. completion date March 2012

Study information
Verified date June 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Adenoid Cystic
  • Carcinoma, Squamous Cell
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • 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

Procedure:
• endoscopic procedure

Other:
• questionnaire administration
Ancillary studies

Locations
Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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