Vocal FoldsNCT02156518
The Efficacy of Vocal Function Exercises for Laryngeal Cancers
A study testing Vocal Function Exercises and Vocal Hygiene in people with Vocal Folds, run by Vrushali Angadi at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Folds
- What is being tested?
- Vocal Function Exercises and Vocal Hygiene
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Adjuvant treatment: laser or any surgical intervention
- Neurological or cognitive impairment
- Hearing levels that interfere with following test instruction
- Vocal fold paralysis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
University of Kentucky
Lexington, Kentucky, 40536
About this study
Official title: Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers
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.
- Conditions
- Vocal Folds
- Being tested
- Vocal Function Exercises, Vocal Hygiene
- Keywords
- radiation therapy, laryngeal cancer, voice therapy, vocal function exercises
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocal Function ExercisesProcedure or surgery
Vocal Function Exercises
Vocal HygieneProcedure or surgery
Vocal Hygiene
| Study group | Role | What they receive |
|---|---|---|
| Vocal Function Exercises | Experimental | Vocal Function Exercises Receives: Procedure: Vocal Function Exercises |
| Vocal hygiene | Active comparator | Vocal hygiene Receives: Procedure: Vocal Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrushali Angadi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vrushali Angadi, University of Kentucky
- Investigators
- Vrushali Angadi, Principal investigator, University of Kentucky, Department of Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156518
- Sponsor's protocol ID
- 2014-027
- Status last verified
- May 2018
- First submitted
- 3 Jun 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers
- ClinicalTrials.gov ID
- NCT02156518
- Acronym / sponsor ID
- 2014-027
- Conditions
- Vocal Folds
- Keywords
- radiation therapy, laryngeal cancer, voice therapy, vocal function exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vrushali AngadiUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vocal Function Exercises | Experimental | Procedure: Vocal Function ExercisesVocal Function Exercises |
| Vocal hygiene | Active comparator | Procedure: Vocal HygieneVocal hygiene |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Adjuvant treatment: laser or any surgical intervention
- Neurological or cognitive impairment
- Hearing levels that interfere with following test instruction
- Vocal fold paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vocal Function ExercisesVocal Function Exercises | Procedure or surgery | Vocal Function Exercises |
| Vocal HygieneVocal Hygiene | Procedure or surgery | Vocal hygiene |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vrushali Angadi principal investigator
University of Kentucky, Department of Rehabilitation Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocal Function Exercises and Vocal Hygiene in people with Vocal Folds, run by Vrushali Angadi at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice production (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.