Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: Pre-treatment swallowing exercises; Other: Post-treatment swallowing exercises.

• Registration Number: NCT00584129
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pre-treatment swallowing exercises	Patients will receive pre-treatment swallowing exercises.
2	Post-treatment swallowing exercises.	Post-treatment swallowing exercises.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

UAB Division of Otolaryngology; 🇺🇸 Birmingham, Alabama, United States