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Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00584129
First received: December 21, 2007
Last updated: October 31, 2011
Last verified: October 2011
History of Changes

December 21, 2007
October 31, 2011
February 2006
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00584129 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Head and Neck Cancer
  • Other: Pre-treatment swallowing exercises
    Swallowing exercises will be started pre-treatment with radiation.
  • Other: Post-treatment swallowing exercises.
    Patients to start swallowing exercises after completion of radiation therapy.
  • Experimental: 1
    Patients will receive pre-treatment swallowing exercises.
    Intervention: Other: Pre-treatment swallowing exercises
  • Active Comparator: 2
    Post-treatment swallowing exercises.
    Intervention: Other: Post-treatment swallowing exercises.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584129
F060123002, F060123002
No
William Carroll, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Principal Investigator: William R. Carroll, MD University of Alabama at Birmingham
University of Alabama at Birmingham
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP