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The Efficacy of Vocal Function Exercises for Laryngeal Cancers

Primary Purpose

Vocal Folds

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vocal Function Exercises

Vocal Hygiene

About this trial

This is an interventional supportive care trial for Vocal Folds focused on measuring radiation therapy, laryngeal cancer, voice therapy, vocal function exercises

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kentucky, Markey Cancer Center
University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vocal Function Exercises

Vocal hygiene

Arm Description

Vocal Function Exercises

Vocal hygiene

Outcomes

Primary Outcome Measures

Voice production

Voice Handicap Index, a validated self- assessment tool was used as the primary outcome measure. A score of 0 indicates no handicap, and a score of 120 indicates complete impairment. Data will be presented as pre and post treatment score (pre and post 6 weeks of therapy).

Secondary Outcome Measures

Full Information

NCT ID

NCT02156518

First Posted

June 3, 2014

Last Updated

May 2, 2018

Sponsor

Vrushali Angadi

1. Study Identification

Unique Protocol Identification Number

NCT02156518

Brief Title

The Efficacy of Vocal Function Exercises for Laryngeal Cancers

Official Title

Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Vrushali Angadi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vocal Folds

Keywords

radiation therapy, laryngeal cancer, voice therapy, vocal function exercises

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vocal Function Exercises

Arm Type

Experimental

Arm Description

Vocal Function Exercises

Arm Title

Vocal hygiene

Arm Type

Active Comparator

Arm Description

Vocal hygiene

Intervention Type

Procedure

Intervention Name(s)

Vocal Function Exercises

Intervention Description

Vocal Function Exercises

Intervention Type

Procedure

Intervention Name(s)

Vocal Hygiene

Intervention Description

Vocal Hygiene

Primary Outcome Measure Information:

Title

Voice production

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vrushali Angadi

Organizational Affiliation

University of Kentucky, Department of Rehabilitation Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky, Markey Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Vocal Function Exercises for Laryngeal Cancers

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