Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia
Determining the Efficacy of Pre-treatment Swallowing Therapy as a Means to Improve Dysphagia Quality of Life When Compared to Post-Treatment Therapy.
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable head-and-neck-cancer
Started Feb 2006
Longer than P75 for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 17, 2015
March 1, 2015
7.8 years
December 21, 2007
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 weeks, 6 months, 12 months post radiation treatment
Secondary Outcomes (1)
To test whether pre-treatment swallowing exercises compared with usual care improves secondary outcome measures related to dysphagia in this patient population.
8 weeks, 6 mnths and 12 months post radiation.
Study Arms (2)
1
EXPERIMENTALPatients will receive pre-treatment swallowing exercises.
2
ACTIVE COMPARATORPost-treatment swallowing exercises.
Interventions
Swallowing exercises will be started pre-treatment with radiation.
Patients to start swallowing exercises after completion of radiation therapy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior cancer diagnosis
- Metastatic disease
- Cognitive Impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAB Division of Otolaryngology
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William R. Carroll, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 2, 2008
Study Start
February 1, 2006
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
March 17, 2015
Record last verified: 2015-03