Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00584129|
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Other: Pre-treatment swallowing exercises Other: Post-treatment swallowing exercises.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||February 2006|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
Patients will receive pre-treatment swallowing exercises.
Other: Pre-treatment swallowing exercises
Swallowing exercises will be started pre-treatment with radiation.
Active Comparator: 2
Post-treatment swallowing exercises.
Other: Post-treatment swallowing exercises.
Patients to start swallowing exercises after completion of radiation therapy.
- 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 ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584129
|United States, Alabama|
|UAB Division of Otolaryngology|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||William R. Carroll, MD||University of Alabama at Birmingham|