The Efficacy of Vocal Function Exercises for Laryngeal Ca... | NCT02156518

Studies
The Efficacy of Vocal Function Exercises for Laryngeal Cancers

NCT02156518

Sponsor

Vrushali Angadi

Status

Completed

Last Update Posted

May 8, 2018Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Vocal Folds

Interventions

Vocal Function Exercises
Vocal Hygiene

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Jun 3, 2014

First Submission Date that Met QC Criteria

Jun 4, 2014

First Posted Date

Jun 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2018

Last Update Posted Date

May 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vocal Function Exercises	Experimental	Vocal Function Exercises	Procedure: Vocal Function Exercises
Vocal hygiene	Active Comparator	Vocal hygiene	Procedure: Vocal Hygiene

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vocal Function Exercises	Procedure	Vocal Function Exercises	Vocal Function Exercises

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vrushali Angadi	University of Kentucky, Department of Rehabilitation Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky, Markey Cancer Center		Lexington	Kentucky	40536	United States
University of Kentucky

Condition Browse Module

MeSH Terms

ID	Term
D007822	Laryngeal Neoplasms

Ancestor Terms

ID	Term
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided