Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

Not Applicable

Completed

• Conditions: Oral Complications of Radiation Therapy; Stage I Laryngeal Cancer; Stage II Laryngeal Cancer
• Interventions: Procedure: laser therapy; Other: questionnaire administration

• Registration Number: NCT02198131
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-23
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (pulsed dye laser)	questionnaire administration	Patients undergo pulsed dye laser monthly for three months.
Supportive Care (pulsed dye laser)	laser therapy	Patients undergo pulsed dye laser monthly for three months.

Primary Outcome Measures

Name	Time	Method
Voice quality using the patient self-assessment questionnaire	Up to 6 months post-treatment	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.
Videostroboscopy rates	Up to 6 months post-treatment	Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.
Change in jitter	Baseline and at 6 months post-treatment	Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in shimmer	Baseline and at 6 months post-treatment	Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in mean phonatory flow	Baseline and at 6 months post-treatment	Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in noise to harmonic ratio	Baseline and at 6 months post-treatment	Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in Voice Handicap Index (VHI)-10 score	Baseline to 6 months post-treatment	The VHI-10 form will be scored and then those numbers will be compared pre and post treatment for each individual.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States