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

Phase 2

Completed

• Conditions: Head & Neck Cancer

• Registration Number: NCT00796952
• Lead Sponsor: University of Florida

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

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 will experience some degree of dysphagia along with nutritional decline. In particular, the swallowing outcome of those patients treated with external beam radiation is suggested to be poorer than those patients treated by surgical interventions alone. It has also been postulated that the formation of radiation-induced fibrotic tissue, along with the acute radiation effects (edema, mucositis, xerostomia) may act collectively to promote muscular disuse or atrophy, and the noted decline in swallowing function. We therefore suggest that a program of swallowing exercises may help facilitate and maintain muscle function in the oral cavity and pharynx during radiotherapy, thus preserving or supporting swallowing function in these patients.

This study will follow a randomized controlled trial design. Patients with confirmed head / neck cancer identified for planned radiotherapy will undergo a baseline evaluation including clinical and instrumental swallowing assessment, nutritional examination, and MRI prior to CRT. Subjects will then be randomized to one of three intervention arms representing control, placebo and intervention groups. Patients will be treated for 6 weeks and progress reassessed at 6 months. Outcome assessment will be completed by a blinded observer. Primary outcomes include; I)Oropharyngeal active muscle volume, signal intensity, and tissue composition over time as identified by T2 weighted MRI, II)Level of functional swallowing ability,III)Patient perception of swallowing function and quality of life.The results of the study will provide information on the efficacy (or lack of efficacy) of isometric / isotonic exercises for the maintenance of swallowing function post radiotherapy for Head /Neck cancer.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2004-07
• Study Completion: 2005-04
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-16
• Last Update Posted: 2011-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI	Baseline, 6 weeks( end of CRT), 6 months(following CRT)
Level of functional swallowing ability- measured by functional eating score (FOIS), clinical swallowing score, videoendoscopy and videofluoroscopic evaluation	Baseline, 6 week(end of CRT), 6 months(following CRT)
Patient perception of swallowing ability	Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Quality of Life	Baseline, 6 weeks (end of CRT), 6 months (following CRT)

Secondary Outcome Measures

Name	Time	Method
Taste perception	Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Perception of smell	Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Salivation rates	Baseline, 6 weeks (end of CRT), 6 months (following CRT)

Trial Locations

Locations (1)

University of Florida, Health Science Center; 🇺🇸 Gainesville, Florida, United States