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NCT00584129 Clinical Trial

Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

Head and Neck Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00584129
Other study ID # F060123002
Secondary ID F060123002
Status Completed
Phase N/A
First received December 21, 2007
Last updated March 12, 2015
Start date February 2006
Est. completion date December 2014

Study information
Verified date March 2015
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• Pre-treatment swallowing exercises
Swallowing exercises will be started pre-treatment with radiation.
• Post-treatment swallowing exercises.
Patients to start swallowing exercises after completion of radiation therapy.

Locations
Country Name City State
United States UAB Division of Otolaryngology Birmingham Alabama

Sponsors (2)
Lead Sponsor Collaborator
University of Alabama at Birmingham American Academy of Otolaryngology-Head and Neck Surgery Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. No
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