Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients
- Conditions
- Head & Neck Cancer
- Interventions
- Behavioral: focused attention sessionsBehavioral: PharyngociseBehavioral: Valchuff
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
- Arm && Interventions
Group Intervention Description Usual Care focused attention sessions Patient management by the attending Radiation oncologist "as usual". Pharyngocise Pharyngocise Standardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their chemo-radiation treatment (up to a maximum of 6 weeks) Valchuff Valchuff Standardised sham swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of chemo-radiation treatment.
- 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