NCT02198131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

6.7 years

First QC Date

July 21, 2014

Last Update Submit

April 24, 2023

Conditions

Oral Complications of Radiation TherapyStage I Laryngeal CancerStage II Laryngeal Cancer

Outcome Measures

Primary Outcomes (7)

  • Videostroboscopy rates

    Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.

    Up to 6 months post-treatment

  • 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.

    Baseline to 6 months post-treatment

  • Change in jitter

    Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.

    Baseline and at 6 months post-treatment

  • 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.

    Up to 6 months post-treatment

  • Change in shimmer

    Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.

    Baseline and at 6 months post-treatment

  • Change in noise to harmonic ratio

    Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.

    Baseline and at 6 months post-treatment

  • Change in mean phonatory flow

    Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.

    Baseline and at 6 months post-treatment

Study Arms (1)

Supportive Care (pulsed dye laser)

EXPERIMENTAL

Patients undergo pulsed dye laser monthly for three months.

Procedure: laser therapyOther: questionnaire administration

Interventions

laser therapyPROCEDURE

Undergo pulsed dye laser

Also known as: therapy, laser
Supportive Care (pulsed dye laser)
questionnaire administrationOTHER

Ancillary studies

Supportive Care (pulsed dye laser)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Carter Wright

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 23, 2014

Study Start

October 1, 2009

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

US(1)