Head and Neck Cancer Clinical Trial
Official title:
Effects of Swallowing Therapy in Head and Neck Cancer
Treatment for head and neck cancer often results in significant swallowing problems because of reduced range of motion (ROM) of the larynx, tongue base, and pharyngeal walls. Our question is: Is swallowing therapy to improve ROM during swallowing maneuvers efficacious in patients with reduced ROM?
Patients with head and neck cancer who are treated with chemoradiation and/or surgical
resection may exhibit a variety of swallowing difficulties due to reduced range of motion
(ROM) resulting from absence or alteration of the structures involved in deglutition.
Chemoradiation protocols have been receiving increased attention in the treatment of head
and neck cancer. The primary focus of these regimens is disease control and organ sparing.
Preservation of oropharyngeal anatomy, however, has not equated with preservation of
function. Due to the severity and frequency of swallowing problems in this population, it is
critical that the effectiveness of dysphagia (i.e. swallowing disorder) rehabilitation
protocols on preservation and/or restoration of function be determined. In the absence of
potential remediation, patients may reject organ preservation treatment protocols because of
negative functional side effects. There have been a number of therapeutic exercises designed
to improve swallowing that have been shown to have a positive effect on head and neck cancer
patients who are dysphagic as a result of treatment with surgery and/or chemoradiation. The
short- and long-term effectiveness of these exercises has not been defined. The purpose of
this study is to compare the effectiveness of combined ROM and postural sensory therapy for
swallowing dysfunction to postural sensory therapy alone. By maximizing the effectiveness of
therapy, it is expected that improved swallowing function will translate into better quality
of life through enjoyment of meals and improved nutrition and hydration so critical to the
health and sense of well being of individuals recovering from head and neck cancer.
To be included, subjects must be between 21 and 80 years old and have undergone treatment
for the head and neck cancer in the form of chemoradiation, and/or one of the following
specific types of head and neck cancer surgery: supraglottic laryngectomy, anterior
resection with primary or skin graft closure, anterior resection with distal or free flap
closure, posterior resection with primary or skin graft closure, or posterior resection with
distal or free flap. Potential subjects must have been diagnosed with Stage I-IV disease and
also be available for twice-weekly swallowing therapy sessions. Furthermore, subjects must
be available for 12 months while on study.
No subject will be included who has any history of other medical problems that may affect
swallowing, speech, voice, neurological problems, gastroenterological problems, or other
health problems as determined by the patient's physician and the investigators. Patients
with prior treated cancer of the head and neck, or who received a total laryngectomy
operation are also not eligible.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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