Vocal Folds Clinical Trial
Official title:
Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers
| NCT number | NCT02156518 |
| Other study ID # | 2014-027 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | March 2018 |
| Verified date | May 2018 |
| Source | University of Kentucky |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | March 2018 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Kentucky | Lexington | Kentucky |
| United States | University of Kentucky, Markey Cancer Center | Lexington | Kentucky |
| Lead Sponsor | Collaborator |
|---|---|
| Vrushali Angadi |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |