The Efficacy of Vocal Function Exercises for Laryngeal Cancers
Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 3, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMay 8, 2018
May 1, 2018
3.7 years
June 3, 2014
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
6 weeks
Study Arms (2)
Vocal Function Exercises
EXPERIMENTALVocal Function Exercises
Vocal hygiene
ACTIVE COMPARATORVocal hygiene
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Adjuvant treatment: laser or any surgical intervention
- Neurological or cognitive impairment
- Hearing levels that interfere with following test instruction
- Vocal fold paralysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vrushali Angadilead
Study Sites (2)
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vrushali Angadi
University of Kentucky, Department of Rehabilitation Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 3, 2014
First Posted
June 5, 2014
Study Start
May 1, 2014
Primary Completion
January 1, 2018
Study Completion
March 1, 2018
Last Updated
May 8, 2018
Record last verified: 2018-05