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

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

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.

Study Overview

• Status: Completed
• Conditions: Head & Neck Cancer
• Intervention / Treatment: Behavioral: focused attention sessions; Behavioral: Pharyngocise; Behavioral: Valchuff

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida, Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Patient management by the attending Radiation oncologist "as usual".	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.
Experimental: 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)	Behavioral: 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)
Sham Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Florida Department of Health
• Investigators: Principal Investigator: Michael Crary, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): July 1, 2004
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: November 21, 2008
• First Submitted That Met QC Criteria: November 21, 2008
• First Posted (Estimate): November 24, 2008

Study Record Updates

• Last Update Posted (Estimate): September 20, 2011
• Last Update Submitted That Met QC Criteria: September 16, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Swallowing; behavioral treatment; Head/ neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: BM009