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Oropharyngeal Function After Radiotherapy With IMRT

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ClinicalTrials.gov Identifier: NCT00506324
Recruitment Status : Terminated (Physician deceased)
First Posted : July 25, 2007
Last Update Posted : July 14, 2015
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:
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 or disease
Head and Neck Neoplasms

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oropharyngeal Function After Radiotherapy With IMRT
Study Start Date : June 2006
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. percent oral intake [ Time Frame: 12 months post-treatment completion ]
    The percent of nutrition taken by mouth

Secondary Outcome Measures :
  1. normal diet [ Time Frame: 12 months post-treatment completion ]
    The patient has a normal diet when he or she includes all consistencies (thin liquid, thick liquid, pudding, pureed, soft mechanical, hard mechanical)

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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506324

United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
Sponsors and Collaborators
Northwestern University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Jerilyn Logemann Northwestern University

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00506324     History of Changes
Other Study ID Numbers: R01DC007659-01A1 ( U.S. NIH Grant/Contract )
R01DC007659 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015

Keywords provided by Northwestern University:
Intensity Modulated Radiotherapy
Head and Neck Neoplasms

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