Pharyngocise Dose Response Study - Full Text View

Purpose

In this study supported by an American Cancer Society grant, the investigators are evaluating two levels of swallowing exercise intensity on the maintenance of swallowing muscles and their function in Head/Neck cancer patients undergoing radiotherapy. Patients in this study are randomly placed into different exercise groups and provided with exercises to perform daily during their radiation treatment. Their progress, diet management and swallowing ability are monitored throughout the treatment period and followed up until 3 months after radiation treatment. In addition to the daily treatment details, the patients perception of their swallowing ability and concerns about their health and treatment are also measured. This clinical trial will help to refine a previously investigated simple exercise package and provide a program of intervention that can help prevent medically related complications of swallowing difficulty (e.g. pneumonia, dehydration, prolonged tube feeding), and improve the ability to eat for patients with head / neck cancer. Ultimately it is hoped that this form of exercise therapy will help reduce the costs (personal and financial) to the patient, caregivers and community.

Condition	Intervention	Phase
Dysphagia	Behavioral: Pharyngocise	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Muscle Preservation and Swallow Function Following Radiotherapy: A Dose Response Study

Resource links provided by NLM:

MedlinePlus related topics: Swallowing Disorders

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Change in T2 Weighted Magnetic Resonance Imaging [ Time Frame: at 3 months after treatment ] [ Designated as safety issue: No ]
T2 Weighted Magnetic Resonance Imaging (MRI) to quantify baseline muscle parameters in the oral cavity and pharynx. The regions of interest will be identified on images using axial and coronal planes. Information regarding the muscle volume, composition (fat Vs muscle Vs edema) as reflected by the signal intensity.
Clinical swallowing Ability [ Time Frame: baseline, 3 weeks, 6 weeks and 3 months post treatment ] [ Designated as safety issue: No ]
Swallowing ability and method/ type of dietary intake, e.g. Functional Oral Intake Scale score [F.O.I.S] over the study period

Secondary Outcome Measures:

Weight [ Time Frame: baseline, 3 weeks, 6 weeks and 3 months post treatment ] [ Designated as safety issue: No ]
Weight and Body Mass Index will be calculated.
Psychosocial functioning [ Time Frame: baseline and 3 months post treatment ] [ Designated as safety issue: No ]
Domain assessments for, quality of life, pain,and fatigue using the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H/N), Pain Disability Index (PDI), Functional Assessment of Cancer Therapy - Anemia (FACT-An) scale, Multidimensional Fatigue Symptom Inventory (MFSI), Profiles of Mood Scale (POMS) and Center for Epidemiologic Studies Depression Scale(CESD).
Instrumental swallowing evaluation [ Time Frame: baseline and 3 months post treatment ] [ Designated as safety issue: No ]
Range of swallowing biomechanics measured from endoscopic and fluorographic evaluations.
Swallowing Quality of Life [ Time Frame: baseline and 3 months post treatment ] [ Designated as safety issue: No ]
Patient perception of effect of swallowing disability - Swallowing Quality of Life (SWAL QOL) score during the study period.


Enrollment:	130
Study Start Date:	June 2006
Study Completion Date:	December 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Usual care Control (Usual care) group in which patients will receive swallowing and prescribed dietary intervention during the radiotherapy period prescribed by the attending physician.
Experimental: High Intensity Pharyngocise Patients receive twice daily swallowing intervention by a speech language pathologist, consisting of the battery of isometric / isotonic exercises.	Behavioral: Pharyngocise swallowing intervention by a speech language pathologist, consisting of the battery of isometric / isotonic exercises
Active Comparator: Low Intensity Pharyngocise Patients will receive a one time only swallowing intervention session by a speech language pathologist, instructing them in the battery of isometric / isotonic exercises plus a home practice instruction digital video tape to support self directed practice of this program at home.	Behavioral: Pharyngocise swallowing intervention by a speech language pathologist, consisting of the battery of isometric / isotonic exercises

Detailed Description:

In an earlier pilot study, a regime of simple swallowing exercises was identified as useful in maintaining oropharyngeal muscle characteristics as measured by T2 weighted Magnetic Resonance Imaging (MRI) and produced a trend toward improved function for swallowing in patients undergoing radiotherapy for head and neck cancer. The purpose of this current study is to evaluate the dose response of two levels of swallowing exercise intensity on the maintenance of muscle composition and function for swallowing in Head/Neck cancer patients undergoing radiotherapy.

HYPOTHESIS: A program of intensive swallowing exercise (Pharyngocise) will maintain muscle function in the oral cavity and pharynx during radiotherapy, preserving or supporting swallowing function in Head/Neck cancer patients.

STUDY DESIGN: 130 patients with Head/Neck cancer, confirmed by clinical history and exam, will be recruited over a 4 year period. All subjects will undergo an initial baseline work up, including a standardized clinical and instrumental swallowing evaluation, psychosocial scales, nutritional exam, and T2 weighted MRI prior to the first radiation therapy. Subjects will be randomized into 1 of 3 groups:

Group A: Usual care (control) group - patients will receive swallowing and prescribed dietary intervention during the radiotherapy period prescribed by the attending physician.

Group B: High intensity pharyngocise treatment group - patients will receive twice daily swallowing intervention by a speech language pathologist, consisting of the battery of isometric/isotonic exercises.

Group C: Low intensity pharyngocise treatment group - patients will receive a single instructional exercise session on the isometric/isotonic exercises from a Speech Language Pathologist and a practice tape to support home practice of the exercises.

All patients will be treated for approximately 6 weeks and followed for 3 months post treatment. Baseline assessments will be repeated. In addition, daily treatment details, patients perception of current swallowing ability and progress in therapy will be recorded by the Speech Pathologist. Participants will be independently monitored throughout the treatment period by researcher blind to the treatment group assigned, via weekly phone interview sessions. Compliance with the treatment techniques, and the occurrence of any negative endpoints such as occurrence of aspiration pneumonia will be recorded.

Eligibility


Ages Eligible for Study:	21 Years to 90 Years (Adult, Senior)
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 external beam radiation therapy
No previous history of non-oral feeding for cancer related illness
Able to undergo MRI imaging scan
Patient and physician agreement to enter the study

Exclusion Criteria:

Planned extensive 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
Gross tumor involvement of the oral and pharyngeal muscles obviating adequate MRI measurements of the majority of muscles of interest.

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: NCT01279837

Locations


United States, Florida
Shands Cancer Center, University of Florida
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

American Cancer Society, Inc.

Investigators


Principal Investigator:	Giselle Carnaby-Mann, PhD	University of Florida

More Information


Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT01279837 History of Changes
Other Study ID Numbers:	RSG-06-103-01(CCE)
Study First Received:	January 7, 2011
Last Updated:	January 4, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:


swallowing disorders swallowing therapy head neck cancer oropharyngeal dysphagia

Additional relevant MeSH terms:


Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases	Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 23, 2016