Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"
21 Years
90 Years
Both
Head & Neck Cancer
Trial Information
Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI
Outcome Time Frame:
Baseline, 6 weeks( end of CRT), 6 months(following CRT)
Safety Issue:
No
Principal Investigator
Giselle Carnaby-Mann, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Florida
Authority:
United States: Institutional Review Board
Study ID:
BM009
NCT ID:
NCT00796952
Start Date:
November 2001
Completion Date:
April 2005
Related Keywords:
- Head & Neck Cancer
- Head/ neck cancer
- Swallowing
- behavioral treatment
- Head and Neck Neoplasms
Name | Location |
|---|---|
| University of Florida, Health Science Center | Gainesville, Florida 32610 |
