Dysphagia Clinical Trial
Official title:
Muscle Preservation and Swallow Function Following Radiotherapy: A Dose Response Study
Verified date | January 2011 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | December 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Shands Cancer Center, University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | American Cancer Society, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in T2 Weighted Magnetic Resonance Imaging | 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. | at 3 months after treatment | No |
Primary | Clinical swallowing Ability | Swallowing ability and method/ type of dietary intake, e.g. Functional Oral Intake Scale score [F.O.I.S] over the study period | baseline, 3 weeks, 6 weeks and 3 months post treatment | No |
Secondary | Weight | Weight and Body Mass Index will be calculated. | baseline, 3 weeks, 6 weeks and 3 months post treatment | No |
Secondary | Psychosocial functioning | 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). | baseline and 3 months post treatment | No |
Secondary | Instrumental swallowing evaluation | Range of swallowing biomechanics measured from endoscopic and fluorographic evaluations. | baseline and 3 months post treatment | No |
Secondary | Swallowing Quality of Life | Patient perception of effect of swallowing disability - Swallowing Quality of Life (SWAL QOL) score during the study period. | baseline and 3 months post treatment | No |
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