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Effects of Swallowing Therapy in Head and Neck Cancer


N/A
21 Years
80 Years
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Effects of Swallowing Therapy in Head and Neck Cancer


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.


Inclusion Criteria:



- Subject 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

Exclusion Criteria:

- history of medical problems that may affect swallowing, speech, voice

- neurological problems

- gastroenterological problems

- prior treatment for cancer of the head and neck

- patient who received a total laryngectomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

improved swallowing function

Outcome Time Frame:

1-month, 4-month, 6-month, and 12-month post treatment

Safety Issue:

No

Principal Investigator

Diane Bless, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2003-373

NCT ID:

NCT00214305

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms

Name

Location

University of WisconsinMadison,, Wisconsin  53792-5666