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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
  Purpose

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.


Condition Intervention
Head and Neck Cancer
 Other: Pre-treatment swallowing exercises
Other: Post-treatment swallowing exercises.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

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. [ Time Frame: 8 weeks, 6 months, 12 months post radiation treatment ] [ Designated as safety issue: No ]

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. [ Time Frame: 8 weeks, 6 mnths and 12 months post radiation. ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584129

Locations
United States, Alabama
UAB Division of Otolaryngology
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Investigators
Principal Investigator: William R. Carroll, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00584129     History of Changes
Other Study ID Numbers: F060123002, F060123002
Study First Received: December 21, 2007
Last Updated: October 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Cancer
Dysphagia
Radiation
Patients with H&N cancer who will be receiving chemoradiation

Additional relevant MeSH terms:
Deglutition Disorders
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Pharyngeal Diseases
Otorhinolaryngologic Diseases
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013