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Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

Primary Purpose

Oral Complications of Radiation Therapy, Stage I Laryngeal Cancer, Stage II Laryngeal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
laser therapy
questionnaire administration
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Complications of Radiation Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suffering from dysphonia after radiation therapy for glottic carcinoma will be included in the study
  • Patients will be included if their initial stage was T1 N0 M0 or T2 N0 M0

Exclusion Criteria:

  • Patients having previously undergone large surgical resections of the larynx or hypopharynx will be excluded
  • Patients fewer than 1 year out from completion of radiation therapy will be excluded
  • Patients with local disease recurrence would be excluded from the trial
  • Patients in whom the transnasal endoscope is poorly tolerated or patients in whom transnasal endoscopic laryngoscopy is contraindicated will be excluded

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (pulsed dye laser)

Arm Description

Patients undergo pulsed dye laser monthly for three months.

Outcomes

Primary Outcome Measures

Videostroboscopy rates
Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.
Change in Voice Handicap Index (VHI)-10 score
The VHI-10 form will be scored and then those numbers will be compared pre and post treatment for each individual.
Change in jitter
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Voice quality using the patient self-assessment questionnaire
The post treatment questionnaire form will be scored and then comparisons made for each individual question on the form across our study group. These values will be discrete variables.
Change in shimmer
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in noise to harmonic ratio
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in mean phonatory flow
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2014
Last Updated
April 24, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02198131
Brief Title
Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia
Official Title
Pulsed Dye Laser for Treatment of Post Radiation Dysphonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot trial studies pulsed dye laser in treating patients with post radiation dysphonia. Dysphonia, or vocal cord scarring, can include trouble with the voice when trying to talk, such as hoarseness, change in voice pitch, and poor voice quality, and it commonly happens after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post radiation dysphonia.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the use of pulsed dye laser in treatment of the dysphonia that commonly results after radiation therapy for laryngeal carcinoma. OUTLINE: Patients undergo pulsed dye laser monthly for three months. After completion of study treatment, patients are followed up at 1, 3, and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Complications of Radiation Therapy, Stage I Laryngeal Cancer, Stage II Laryngeal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (pulsed dye laser)
Arm Type
Experimental
Arm Description
Patients undergo pulsed dye laser monthly for three months.
Intervention Type
Procedure
Intervention Name(s)
laser therapy
Other Intervention Name(s)
therapy, laser
Intervention Description
Undergo pulsed dye laser
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Videostroboscopy rates
Description
Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.
Time Frame
Up to 6 months post-treatment
Title
Change in Voice Handicap Index (VHI)-10 score
Description
The VHI-10 form will be scored and then those numbers will be compared pre and post treatment for each individual.
Time Frame
Baseline to 6 months post-treatment
Title
Change in jitter
Description
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Time Frame
Baseline and at 6 months post-treatment
Title
Voice quality using the patient self-assessment questionnaire
Description
The post treatment questionnaire form will be scored and then comparisons made for each individual question on the form across our study group. These values will be discrete variables.
Time Frame
Up to 6 months post-treatment
Title
Change in shimmer
Description
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Time Frame
Baseline and at 6 months post-treatment
Title
Change in noise to harmonic ratio
Description
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Time Frame
Baseline and at 6 months post-treatment
Title
Change in mean phonatory flow
Description
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Time Frame
Baseline and at 6 months post-treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from dysphonia after radiation therapy for glottic carcinoma will be included in the study Patients will be included if their initial stage was T1 N0 M0 or T2 N0 M0 Exclusion Criteria: Patients having previously undergone large surgical resections of the larynx or hypopharynx will be excluded Patients fewer than 1 year out from completion of radiation therapy will be excluded Patients with local disease recurrence would be excluded from the trial Patients in whom the transnasal endoscope is poorly tolerated or patients in whom transnasal endoscopic laryngoscopy is contraindicated will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carter Wright
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

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