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Muscle Preservation and Swallow Function Following Radiotherapy: A Dose Response Study


Phase 2/Phase 3
21 Years
90 Years
Not Enrolling
Both
Dysphagia

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Trial Information

Muscle Preservation and Swallow Function Following Radiotherapy: A Dose Response Study


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change in T2 Weighted Magnetic Resonance Imaging

Outcome Description:

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.

Outcome Time Frame:

at 3 months after treatment

Safety Issue:

No

Principal Investigator

Giselle Carnaby-Mann, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Institutional Review Board

Study ID:

RSG-06-103-01(CCE)

NCT ID:

NCT01279837

Start Date:

June 2006

Completion Date:

December 2011

Related Keywords:

  • Dysphagia
  • swallowing disorders
  • swallowing therapy
  • head neck cancer
  • oropharyngeal dysphagia
  • Deglutition Disorders

Name

Location

Shands Cancer Center, University of FloridaGainesville, Florida  32610