Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00584129
• Collaborator: American Academy of Otolaryngology-Head and Neck Surgery Foundation (Other)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 106
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: Pre-treatment swallowing exercises; Other: Post-treatment swallowing exercises.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• 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: Feb 1, 2006
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00584129
• Other Study ID Numbers: F060123002; F060123002
• First Posted: Jan 2, 2008
• Last Update Posted: Mar 17, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham: Cancer; Dysphagia; Radiation; Patients with H&N cancer who will be receiving chemoradiation
• Additional relevant MeSH terms: Deglutition Disorders

Study Results

No Results Posted as of Mar 17, 2015