Pharyngocise Dose Response Study

Completed · Phase 2/Phase 3

Conditions studied: Dysphagia

In brief

In this study supported by an American Cancer Society grant, the investigators are evaluating two levels of swallowing exercise intensity on the maintenance of swallowing muscles and their function in Head/Neck cancer patients undergoing radiotherapy. Patients in this study are randomly placed into different exercise groups and provided with exercises to perform daily during their radiation treatment. Their progress, diet management and swallowing ability are monitored throughout the treatment period and followed up until 3 months after radiation treatment. In addition to the daily treatment details, the patients perception of their swallowing ability and concerns about their health and treatment are also measured. This clinical trial will help to refine a previously investigated simple exercise package and provide a program of intervention that can help prevent medically related complications of swallowing difficulty (e.g. pneumonia, dehydration, prolonged tube feeding), and improve the ability to eat for patients with head / neck cancer. Ultimately it is hoped that this form of exercise therapy will help reduce the costs (personal and financial) to the patient, caregivers and community.

Key facts

Study ID

NCT01279837

Run by

University of Florida

People needed

130

Starts

2006-06-01

Expected to finish

2011-12-01

Last updated by the study team

2012-01-05

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 external beam radiation therapy
• No previous history of non-oral feeding for cancer related illness
• Able to undergo MRI imaging scan
• Patient and physician agreement to enter the study

You may not qualify if…

• Planned extensive 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
• Gross tumor involvement of the oral and pharyngeal muscles obviating adequate MRI measurements of the majority of muscles of interest.

Where it is running

• Shands Cancer Center, University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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