Clinical trial NCT00796952: Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients
Official title: Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head & Neck Cancer
Keywords: Head/ neck cancer
Swallowing
behavioral treatment
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2008-11-24
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI
timeFrame: Baseline, 6 weeks( end of CRT), 6 months(following CRT)
measure: Level of functional swallowing ability- measured by functional eating score (FOIS), clinical swallowing score, videoendoscopy and videofluoroscopic evaluation
timeFrame: Baseline, 6 week(end of CRT), 6 months(following CRT)
measure: Patient perception of swallowing ability
timeFrame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
measure: Quality of Life
timeFrame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Secondary outcomes:
measure: Taste perception
timeFrame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
measure: Perception of smell
timeFrame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
measure: Salivation rates
timeFrame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida, Health Science Center
state: Florida
Study officials:
affiliation: University of Florida
name: Giselle Carnaby-Mann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Michael Crary, PhD
role: PRINCIPAL_INVESTIGATOR
References: