The Efficacy of Vocal Function Exercises for Laryngeal Cancers

NCT ID: NCT02156518

Last Updated: 2018-05-08

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-03-31

Brief Summary

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The purpose of this study is to determine if the systematic practice of Vocal Function Exercises (VFE) improves selected measures of voice production in participants who have previously been irradiated for early glottic cancers compared to participants who receive the present standard of care, namely, vocal hygiene counseling. It is hypothesized that a prescriptive vocal exercise program (VFE) will improve the voice production of individuals who have been previously treated for laryngeal cancers when compared to participants who receive vocal hygiene alone.

Detailed Description

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Conditions

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Vocal Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vocal Function Exercises

Vocal Function Exercises

Group Type EXPERIMENTAL

Vocal Function Exercises

Intervention Type PROCEDURE

Vocal Function Exercises

Vocal hygiene

Vocal hygiene

Group Type ACTIVE_COMPARATOR

Vocal Hygiene

Intervention Type PROCEDURE

Vocal Hygiene

Interventions

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Vocal Function Exercises

Vocal Function Exercises

Intervention Type PROCEDURE

Vocal Hygiene

Vocal Hygiene

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Hearing level and cognitive ability to follow test directions
* Laryngeal cancer
* Radiation Therapy completed \>= 6 months
* Deemed disease free by the treating physician
* Subjects have to be willing to attend weekly voice therapy sessions

Exclusion Criteria

* Adjuvant treatment: laser or any surgical intervention
* Neurological or cognitive impairment
* Hearing levels that interfere with following test instruction
* Vocal fold paralysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vrushali Angadi

OTHER

Sponsor Role lead

Responsible Party

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Vrushali Angadi

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vrushali Angadi

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky, Department of Rehabilitation Sciences

Locations

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University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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2014-027

Identifier Type: -

Identifier Source: org_study_id

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