Clinical trial NCT01279837: Pharyngocise Dose Response Study
Official title: Muscle Preservation and Swallow Function Following Radiotherapy: A Dose Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dysphagia
Keywords: swallowing disorders
swallowing therapy
head neck cancer
oropharyngeal dysphagia
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2011-01-19
Enrollment: 130
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Change in T2 Weighted Magnetic Resonance Imaging
timeFrame: at 3 months after treatment
measure: Clinical swallowing Ability
timeFrame: baseline, 3 weeks, 6 weeks and 3 months post treatment
Secondary outcomes:
measure: Weight
timeFrame: baseline, 3 weeks, 6 weeks and 3 months post treatment
measure: Psychosocial functioning
timeFrame: baseline and 3 months post treatment
measure: Instrumental swallowing evaluation
timeFrame: baseline and 3 months post treatment
measure: Swallowing Quality of Life
timeFrame: baseline and 3 months post treatment
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Cancer Center, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Giselle Carnaby-Mann, PhD
role: PRINCIPAL_INVESTIGATOR
References: