Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214305
Status:
WITHDRAWN
Last Update Posted:
2015-10-02
First Post:
2005-09-13
Brief Title:
Effects of Swallowing Therapy in Head and Neck Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Effects of Swallowing Therapy in Head and Neck Cancer
Status:
WITHDRAWN
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Patients with head and neck cancer who are treated with chemoradiation andor 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 ie swallowing disorder rehabilitation protocols on preservation andor 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 andor 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 andor 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 patients 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
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 andor 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None