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

This study has been completed.
Sponsor:
Collaborator:
Florida Department of Health
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00796952
First received: November 21, 2008
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Head & Neck Cancer
Behavioral: focused attention sessions
Behavioral: Valchuff
Behavioral: Pharyngocise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI [ Time Frame: Baseline, 6 weeks( end of CRT), 6 months(following CRT) ] [ Designated as safety issue: No ]
  • Level of functional swallowing ability- measured by functional eating score (FOIS), clinical swallowing score, videoendoscopy and videofluoroscopic evaluation [ Time Frame: Baseline, 6 week(end of CRT), 6 months(following CRT) ] [ Designated as safety issue: No ]
  • Patient perception of swallowing ability [ Time Frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Taste perception [ Time Frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT) ] [ Designated as safety issue: No ]
  • Perception of smell [ Time Frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT) ] [ Designated as safety issue: No ]
  • Salivation rates [ Time Frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT) ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: November 2001
Study Completion Date: April 2005
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796952

Locations
United States, Florida
University of Florida, Health Science Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Florida Department of Health
Investigators
Principal Investigator: Giselle Carnaby-Mann, PhD University of Florida
Principal Investigator: Michael Crary, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00796952     History of Changes
Other Study ID Numbers: BM009
Study First Received: November 21, 2008
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Head/ neck cancer
Swallowing
behavioral treatment

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014