- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00584129
Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia
March 12, 2015 updated by: William Carroll, MD, University of Alabama at Birmingham
Determining the Efficacy of Pre-treatment Swallowing Therapy as a Means to Improve Dysphagia Quality of Life When Compared to Post-Treatment Therapy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35294
- UAB Division of Otolaryngology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Patients will receive pre-treatment swallowing exercises.
|
Swallowing exercises will be started pre-treatment with radiation.
|
Active Comparator: 2
Post-treatment swallowing exercises.
|
Patients to start swallowing exercises after completion of radiation therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
8 weeks, 6 months, 12 months post radiation treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
8 weeks, 6 mnths and 12 months post radiation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William R. Carroll, MD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 31, 2007
First Posted (Estimate)
January 2, 2008
Study Record Updates
Last Update Posted (Estimate)
March 17, 2015
Last Update Submitted That Met QC Criteria
March 12, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F060123002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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