Clinical Trial NCI 06CC4
- Oropharyngeal Function After Radiotherapy with IMRT
- Principal Investigator
- Jerilyn Logemann
- Status: COMPLETED
- Study Type: Observation, QOL
- Protocol No:.NCI 06CC4
- This study is performed to examine the effects of a cancer treatment called IMRT (Intensity Modulated Radiotherapy) on swallowing and eating. The purpose of the investigation is to learn the kind of swallowing and eating problems experienced by participants with head and neck cancer who are treated with IMRT. Participants are asked to take part in this study because treatment for a cancerous lesion in the mouth or throat with IMRT will be received.
- Patients who have been treated for cancer of the head and neck with other treatments such as surgery or standard radiation often experience difficulties with swallowing, yet little is known about the kinds of swallowing problems patients may have after treatment with IMRT. Participants will be asked to come to Northwestern Memorial Hospital’s Outpatient Radiology Department, 4th Floor Galter Pavilion, and the Voice, Speech, and Swallowing Service, 676 N. St. Clair Street, Suite 1775. Participation in this study will last up to 24 months depending upon the date of enrollment in the study and will involve up to 6 visits. Procedures will be performed before treatment begins, and at 1, 3, 6,12 and 24 months after completion of treatment. The entire evaluation takes approximately 75 minutes including waiting time at each assessment. The procedures listed will take place during the same visit to Northwestern Memorial Hospital. None of the procedures used in this study are experimental.
Some of the eligibility criteria include:
- Participants must have Stage III or IV (that is at least T1 with nodal involvement or T2) squamous cell carcinoma of the oral cavity, pharynx, or larynx, or unknown primary, and be scheduled for treatment with IMRT.
- Participants must be between 21 and 80 years of age
- Participants must have sufficient English language skills to understand the consent form and study instructions
- Participants must sign a consent form after procedures are explained by the investigator. This consent form must be witnessed and dated
- Participants must anticipate being available for 12 to 24 months while on study
- Description of Treatment
- The visit schedule for this study is as follows; Visit 1 (Pre-cancer treatment)including Videofluoroscopy, Esophageal and Pharyngeal Manometry, Saliva Test,Oral Examination and Completion of Forms. Subsequent visits will be scheduled as follows; Visit 2 (1 month after completing your cancer treatment), Visit 3 (3 months after completing your cancer treatment), Visit 4 (6 months after completing your cancer treatment), Visit 5 (12 months after completing your cancer treatment) and Visit 6 (24 months after completing your cancer treatment).
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 24-Jul-16 01:46 AM
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