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Clinical Trials/NCT02156518
NCT02156518
Completed
Not Applicable

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

Vrushali Angadi2 sites in 1 country12 target enrollmentMay 2014
ConditionsVocal Folds

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vocal Folds
Sponsor
Vrushali Angadi
Enrollment
12
Locations
2
Primary Endpoint
Voice production
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
March 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vrushali Angadi
Responsible Party
Sponsor Investigator
Principal Investigator

Vrushali Angadi

Principal Investigator

University of Kentucky

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

Outcomes

Primary Outcomes

Voice production

Time Frame: 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).

Study Sites (2)

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