The Efficacy of Vocal Function Exercises for Laryngeal Cancers

Not Applicable

Completed

• Conditions: Vocal Folds
• Interventions: Procedure: Vocal Function Exercises; Procedure: Vocal Hygiene

• Registration Number: NCT02156518
• Lead Sponsor: Vrushali Angadi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-05
• Primary Completion: 2018-01
• Study Completion: 2018-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vocal Function Exercises	Vocal Function Exercises	Vocal Function Exercises
Vocal hygiene	Vocal Hygiene	Vocal hygiene

Primary Outcome Measures

Name	Time	Method
Voice production	6 weeks	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).

Trial Locations

Locations (2)

University of Kentucky, Markey Cancer Center; 🇺🇸 Lexington, Kentucky, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States