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Oropharyngeal Function After Radiotherapy With IMRT
This study is currently recruiting participants.
Verified by National Institute on Deafness and Other Communication Disorders (NIDCD), April 2009
First Received: July 20, 2007   Last Updated: April 22, 2009   History of Changes
Sponsored by: National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by: National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier: NCT00506324
  Purpose

This project defines the effect on swallowing of intensity modulation during radiotherapy in an organ preservation treatment involving chemoradiation for 125 oral, laryngeal, and pharyngeal cancer patients with previously untreated Stage III or IV disease and to identify optimum treatment strategies. The specific aims are: 1) define the physiologic effects of chemoradiotherapy with IMRT to various sites in the upper aerodigestive/vocal tract including the cervical esophagus and the rate at which patients return to oral intake; 2) document the acute toxicities, late complications, locoregional failure and survival, and the relationship between fibrosis rating and the measure of laryngeal elevation; 3) determine whether the patient's swallowing mechanism can compensate for physiologic deficits in swallowing by introduction of interventions (postural changes, voluntary swallow maneuvers, several bolus volumes); 4) determine whether time to return to oral intake, effects of swallow maneuvers and/or volume, presence of an esophageal stricture and the duration of success of dilatation depends on radiation dose volume to specific structures in the head and neck; 5) define the relationship of tongue base pressure to development of esophageal stricture. Patients will be accrued from Northwestern University and University of Chicago. Effects are defined in terms of swallowing function, morbidity, toxicity and survival. Other outcome measures are the maintenance of voluntary control (flexibility) of the oropharyngeal region as indicated by the ability to correctly produce swallow maneuvers; and positive changes in cricopharyngeal opening duration with normal bolus volume shifts. Patients will be studied pretreatment, and at 1 month, 3 months, 6 months, 12 months, and 24 months post completion of chemoradiation. At each assessment, patients will receive a videofluoroscopic assessment of swallowing utilizing a standard protocol, assessment of xerostomia, mucositis, and fibrosis as well as assessment of disease status and quality of life scales. Head and neck cancer is a severe problem that affects public health. Most current treatments are a combination of radiotherapy with chemotherapy, which can result in severe swallowing problems which may make patients unwilling to accept this type of treatment. This project attempts to quantify the swallow problems associated with this specific treatment and the effects of interventions for these swallow problems.


Condition
Head and Neck Neoplasms

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Oropharyngeal Function After Radiotherapy With IMRT

Resource links provided by NLM:


Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 125
Study Start Date: June 2006
Estimated Study Completion Date: June 2011
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

One hundred and twenty-five patients with disease Stages III or IV squamous cell cancers of the oral cavity, larynx or pharynx will serve as subjects. No patient will have had prior treatment for head and neck cancer or any otolaryngologic or neurologic disorder affecting swallow, and no preexisting swallowing disorder.

Criteria

Inclusion Criteria:

  • The target population for this study is 125 patients with stages III or IV squamous cell lesions of the oral cavity, oropharynx, pharynx or larynx, or unknown primary.

Exclusion Criteria:

  • No patient will have had prior treatment for head and neck cancer or any otolaryngologic or neurologic disorder affecting swallow and no preexisting swallowing disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506324

Contacts
Contact: Jerilyn Logemann, Ph.D. 847-491-2490 j-logemann@northwestern.edu
Contact: Barbara Pauloski, Ph.D. 847-491-2426 pauloski@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Principal Investigator: Jeri A. Logemann, Ph.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Jerilyn Logemann Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University ( Jeri A. Logemann, Ph.D., Professor )
Study ID Numbers: R01DC007659-01A1
Study First Received: July 20, 2007
Last Updated: April 22, 2009
ClinicalTrials.gov Identifier: NCT00506324     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
Intensity Modulated Radiotherapy
Chemotherapy
Head and Neck Neoplasms
Dysphagia

Study placed in the following topic categories:
Deglutition Disorders
Head and Neck Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009