Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Head & Neck Cancer

In brief

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 battery of isometric / isotonic exercises on the maintenance of muscle composition and function for swallowing in Head / Neck Cancer patients undergoing chemo-radiation therapy.

Key facts

Study ID

NCT00796952

Run by

University of Florida

People needed

58

Starts

2001-11-01

Expected to finish

2005-04-01

Last updated by the study team

2011-09-20

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida, Health Science Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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