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

Head & Neck Cancer Clinical Trial

— Pharyngocise  

Official title:

Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796952
• Other study ID #: BM009
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2008
• Last updated: September 16, 2011
• Start date: November 2001
• Est. completion date: April 2005

Study information

• Verified date: September 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2005
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head & Neck Cancer

Intervention

Behavioral:
• focused attention sessions
Patient management by the attending Radiation oncologist "as usual". Patients assigned to this condition received focused attention sessions during the total course of their CRT treatment from a Speech Language Pathologist, consisting of weekly phone calls to monitor their swallowing outcome during the radiotherapy period.
• Valchuff
Standardised sham or placebo 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 CRT treatment.
• 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 CRT treatment (up to a maximum of 6 weeks)

Locations

Country	Name	City	State
United States	University of Florida, Health Science Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI		Baseline, 6 weeks( end of CRT), 6 months(following CRT)	No
Primary	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)	No
Primary	Patient perception of swallowing ability		Baseline, 6 weeks (end of CRT), 6 months (following CRT)	No
Primary	Quality of Life		Baseline, 6 weeks (end of CRT), 6 months (following CRT)	No
Secondary	Taste perception		Baseline, 6 weeks (end of CRT), 6 months (following CRT)	No
Secondary	Perception of smell		Baseline, 6 weeks (end of CRT), 6 months (following CRT)	No
Secondary	Salivation rates		Baseline, 6 weeks (end of CRT), 6 months (following CRT)	No