Pharyngocise Dose Response Study

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Dysphagia	Behavioral: Pharyngocise	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	130 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Double (Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Muscle Preservation and Swallow Function Following Radiotherapy: A Dose Response Study
Study Start Date :	June 2006
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change in T2 Weighted Magnetic Resonance Imaging [ Time Frame: at 3 months after treatment ]
   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.
2. Clinical swallowing Ability [ Time Frame: baseline, 3 weeks, 6 weeks and 3 months post treatment ]
   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 :

1. Weight [ Time Frame: baseline, 3 weeks, 6 weeks and 3 months post treatment ]
   Weight and Body Mass Index will be calculated.
2. Psychosocial functioning [ Time Frame: baseline and 3 months post treatment ]
   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).
3. Instrumental swallowing evaluation [ Time Frame: baseline and 3 months post treatment ]
   Range of swallowing biomechanics measured from endoscopic and fluorographic evaluations.
4. Swallowing Quality of Life [ Time Frame: baseline and 3 months post treatment ]
   Patient perception of effect of swallowing disability - Swallowing Quality of Life (SWAL QOL) score during the study period.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. 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.
2. Planned external beam radiation therapy
3. No previous history of non-oral feeding for cancer related illness
4. Able to undergo MRI imaging scan
5. Patient and physician agreement to enter the study

Exclusion Criteria:

1. Planned extensive surgical intervention
2. Existence of a co-existing neurological or medical disorder known to cause dysphagia
3. Prior radiotherapy or surgery to the head / neck region that could contribute to dysphagia.
4. Previous swallowing therapy within four weeks of randomization
5. Gross tumor involvement of the oral and pharyngeal muscles obviating adequate MRI measurements of the majority of muscles of interest.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT01279837 History of Changes
Other Study ID Numbers:	RSG-06-103-01(CCE)
First Posted:	January 19, 2011
Last Update Posted:	January 5, 2012
Last Verified:	January 2011

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