Status:
COMPLETED
Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Florida Department of Health
Conditions:
Head & Neck Cancer
Eligibility:
All Genders
21-90 years
Phase:
PHASE2
Brief Summary
Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for how it should be managed. This pilot randomized controlled trial evaluated the relative benefit of a batte...
Detailed Description
Swallowing deficits resulting from oropharyngeal cancer and the ablative therapies used to control the disease are often devastating to the functional feeding outcome in these patients. Most patients ...
Eligibility Criteria
Inclusion
- Head / neck cancer of the oropharyngeal or adjacent regions, confirmed by clinical history and exam, with positive cross sectional imaging studies and histopathological biopsy excluding other pathology.
- Planned to undergo external beam radiation therapy,
- No previous history of nonoral feeding for cancer related illness,
- Able to undergo MRI procedures.
- Physician / patient agreement to participate
Exclusion
- Planned surgical intervention
- Existence of a co-existing neurological or medical disorder known to cause dysphagia
- Prior radiotherapy or surgery to the head / neck region that could contribute to dysphagia.
- Previous swallowing therapy within four weeks of randomization
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00796952
Start Date
November 1 2001
End Date
April 1 2005
Last Update
September 20 2011
Active Locations (1)
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1
University of Florida, Health Science Center
Gainesville, Florida, United States, 32610