Back to resultsPre-treatment Exercises Versus Post-treatment Exercises for Dysphagia
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-treatment swallowing exercises
Post-treatment swallowing exercises.
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Cancer, Dysphagia, Radiation, Patients with H&N cancer who will be receiving chemoradiation
Eligibility Criteria
Inclusion Criteria:
- Stage III or IV squamous cell cancer of teh pharynx and larynx
- Patients who will be receiving chemoradiation
- Age 19 years of age or older
- Must sign informed consent.
Exclusion Criteria:
- Prior cancer diagnosis
- Metastatic disease
- Cognitive Impairment
Sites / Locations
- UAB Division of Otolaryngology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Patients will receive pre-treatment swallowing exercises.
Post-treatment swallowing exercises.
Outcomes
Primary Outcome Measures
To test whether pre-treatment swallowing exercises compared with "usual care" (where exercises are taught post-treatment) improves quality of life in patients undergoing chemoradiation therapy for advanced head and neck cancer.
Secondary Outcome Measures
To test whether pre-treatment swallowing exercises compared with usual care improves secondary outcome measures related to dysphagia in this patient population.
Full Information
NCT ID
NCT00584129
First Posted
December 21, 2007
Last Updated
March 12, 2015
Sponsor
University of Alabama at Birmingham
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00584129
Brief Title
Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia
Official Title
Determining the Efficacy of Pre-treatment Swallowing Therapy as a Means to Improve Dysphagia Quality of Life When Compared to Post-Treatment Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to determine if pre-treatment swallowing exercises can improve post-treatment swallowing function in patients undergoing radiation with or without chemotherapy for advanced squamous cell carcinoma of the head and neck.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Cancer, Dysphagia, Radiation, Patients with H&N cancer who will be receiving chemoradiation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive pre-treatment swallowing exercises.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Post-treatment swallowing exercises.
Intervention Type
Other
Intervention Name(s)
Pre-treatment swallowing exercises
Intervention Description
Swallowing exercises will be started pre-treatment with radiation.
Intervention Type
Other
Intervention Name(s)
Post-treatment swallowing exercises.
Intervention Description
Patients to start swallowing exercises after completion of radiation therapy.
Primary Outcome Measure Information:
Title
To test whether pre-treatment swallowing exercises compared with "usual care" (where exercises are taught post-treatment) improves quality of life in patients undergoing chemoradiation therapy for advanced head and neck cancer.
Time Frame
8 weeks, 6 months, 12 months post radiation treatment
Secondary Outcome Measure Information:
Title
To test whether pre-treatment swallowing exercises compared with usual care improves secondary outcome measures related to dysphagia in this patient population.
Time Frame
8 weeks, 6 mnths and 12 months post radiation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III or IV squamous cell cancer of teh pharynx and larynx
Patients who will be receiving chemoradiation
Age 19 years of age or older
Must sign informed consent.
Exclusion Criteria:
Prior cancer diagnosis
Metastatic disease
Cognitive Impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William R. Carroll, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Division of Otolaryngology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
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Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia
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