Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

Pulsed Dye Laser for Treatment of Post Radiation Dysphonia

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.

Study Overview

• Status: Completed
• Conditions: Oral Complications of Radiation Therapy; Stage I Laryngeal Cancer; Stage II Laryngeal Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: laser therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (pulsed dye laser); Patients undergo pulsed dye laser monthly for three months.	Other: questionnaire administration; Ancillary studies; Procedure: laser therapy; Undergo pulsed dye laser; Other Names: therapy, laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Laryngeal Diseases; Voice Disorders; Laryngeal Neoplasms; Dysphonia
• Other Study ID Numbers: IRB00011092; P30CA012197 (U.S. NIH Grant/Contract); NCI-2014-01458 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 98214 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No