Oropharyngeal Function After Radiotherapy With IMRT
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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: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Oropharyngeal Function After Radiotherapy With IMRT |
- percent oral intake [ Time Frame: 12 months post-treatment completion ] [ Designated as safety issue: No ]The percent of nutrition taken by mouth
- normal diet [ Time Frame: 12 months post-treatment completion ] [ Designated as safety issue: No ]The patient has a normal diet when he or she includes all consistencies (thin liquid, thick liquid, pudding, pureed, soft mechanical, hard mechanical)
| Estimated Enrollment: | 125 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
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 |
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.
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Evanston, Illinois, United States, 60208 | |
| Principal Investigator: | Jerilyn Logemann | Northwestern University |
More Information
No publications provided
| Responsible Party: | Jeri Logemann, Professor, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00506324 History of Changes |
| Other Study ID Numbers: | R01DC007659-01A1, R01DC007659 |
| Study First Received: | July 20, 2007 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
Intensity Modulated Radiotherapy Chemotherapy Head and Neck Neoplasms Dysphagia |
Additional relevant MeSH terms:
|
Neoplasms Head and Neck Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 21, 2013