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Completed

NCT Number: NCT02198131

Pulsed Dye Laser in Treating Patients With 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.

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Key information

Conditions

Oral Complications of Radiation Therapy Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stage I Laryngeal Cancer Stage II Laryngeal Cancer

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laser therapy

Procedure

Undergo pulsed dye laser

Other names: therapy, laser

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Videostroboscopy rates

    Time frame: Up to 6 months post-treatment

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

  2. Change in Voice Handicap Index (VHI)-10 score

    Time frame: 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.

  3. Change in jitter

    Time frame: Baseline and at 6 months post-treatment

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

  4. Voice quality using the patient self-assessment questionnaire

    Time frame: 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.

  5. Change in shimmer

    Time frame: Baseline and at 6 months post-treatment

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

  6. Change in noise to harmonic ratio

    Time frame: Baseline and at 6 months post-treatment

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

  7. Change in mean phonatory flow

    Time frame: Baseline and at 6 months post-treatment

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pulsed Dye Laser for Treatment of Post Radiation Dysphonia

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jul 23, 2014
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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