Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

NCT ID: NCT02198131

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (pulsed dye laser)

Patients undergo pulsed dye laser monthly for three months.

Group Type EXPERIMENTAL

laser therapy

Intervention Type PROCEDURE

Undergo pulsed dye laser

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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laser therapy

Undergo pulsed dye laser

Intervention Type PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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therapy, laser

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carter Wright

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2014-01458

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 98214

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00011092

Identifier Type: -

Identifier Source: org_study_id

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