Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments pre-treatment swallowing exercises, post-treatment swallowing exercises.
Sponsor University of Alabama at Birmingham
Collaborator American Academy of Otolaryngology-Head and Neck Surgery Foundation
Start date February 2006
End date December 2013
Trial size 90 participants
Trial identifier NCT00584129, F060123002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients will receive pre-treatment swallowing exercises.
pre-treatment swallowing exercises
Swallowing exercises will be started pre-treatment with radiation.
(Active Comparator)
Post-treatment swallowing exercises.
post-treatment swallowing exercises.
Patients to start swallowing exercises after completion of radiation therapy.

Primary Outcomes

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

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

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.
Principal investigator William R. Carroll, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.