Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

NCT ID: NCT00584129

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Patients will receive pre-treatment swallowing exercises.

Group Type EXPERIMENTAL

Pre-treatment swallowing exercises

Intervention Type OTHER

Swallowing exercises will be started pre-treatment with radiation.

2

Post-treatment swallowing exercises.

Group Type ACTIVE_COMPARATOR

Post-treatment swallowing exercises.

Intervention Type OTHER

Patients to start swallowing exercises after completion of radiation therapy.

Interventions

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Pre-treatment swallowing exercises

Swallowing exercises will be started pre-treatment with radiation.

Intervention Type OTHER

Post-treatment swallowing exercises.

Patients to start swallowing exercises after completion of radiation therapy.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Otolaryngology-Head and Neck Surgery Foundation

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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William Carroll, MD

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William R. Carroll, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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UAB Division of Otolaryngology

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F060123002

Identifier Type: -

Identifier Source: secondary_id

F060123002

Identifier Type: -

Identifier Source: org_study_id

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