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Clinical Trials/NCT02156518
NCT02156518CompletedNot 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 enrollmentStarted: May 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
2
Primary Endpoint
Voice production

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Vocal Function Exercises

Experimental

Vocal Function Exercises

Intervention: Vocal Function Exercises (Procedure)

Vocal hygiene

Active Comparator

Vocal hygiene

Intervention: Vocal Hygiene (Procedure)

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Vrushali Angadi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Vrushali Angadi

Principal Investigator

University of Kentucky

Study Sites (2)

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