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Pharyngocise Dose Response Study

This study has been completed.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01279837
First received: January 7, 2011
Last updated: January 4, 2012
Last verified: January 2011
History of Changes
  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:

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
Other Name: Pharyngocise
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
Other Name: Pharyngocise

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
Genders Eligible for Study:   Both
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
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

No publications provided

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 June 17, 2013