Dysphagia Clinical Trial
Official title:
Muscle Preservation and Swallow Function Following Radiotherapy: A Dose Response Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03711474 -
Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)
|
Phase 4 | |
Enrolling by invitation |
NCT04074356 -
Non-invasive Markers of Esophageal Function in Adults
|
N/A | |
Suspended |
NCT04349462 -
Post Critical Illness Dysphagia in the Intensive Care Unit
|
N/A | |
Not yet recruiting |
NCT05982977 -
Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
|
N/A | |
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Active, not recruiting |
NCT03455608 -
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
|
N/A | |
Active, not recruiting |
NCT03604822 -
Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS
|
N/A | |
Recruiting |
NCT03682081 -
Interventions for Patients With Alzheimer's Disease and Dysphagia
|
N/A | |
Completed |
NCT05700838 -
Refining Cough Skill Training in Parkinson's Disease and Dysphagia
|
Phase 1 | |
Not yet recruiting |
NCT04064333 -
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
|
N/A | |
Not yet recruiting |
NCT02724761 -
Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion
|
N/A | |
Completed |
NCT02927691 -
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
|
Phase 2 | |
Completed |
NCT01919112 -
Fostering Eating After Stroke With Transcranial Direct Current Stimulation
|
N/A | |
Completed |
NCT01370083 -
Tongue Pressure Profile Training for Dysphagia Post Stroke
|
Phase 2 | |
Withdrawn |
NCT01200147 -
Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
|
N/A | |
Completed |
NCT01723358 -
Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia
|
Phase 2 | |
Completed |
NCT00570557 -
Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia
|
N/A | |
Recruiting |
NCT00166751 -
Sonographic Assessment of Laryngeal Elevation
|
N/A | |
Completed |
NCT01476241 -
Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist
|
N/A | |
Completed |
NCT00717028 -
Functional Endoscopic Evaluation of Swallowing
|
N/A |