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: March 25, 2014
Last verified: March 2014
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 25, 2014
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:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014