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Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

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

Treatments

Other: questionnaire administration
Procedure: laser therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02198131
P30CA012197 (U.S. NIH Grant/Contract)
IRB00011092
NCI-2014-01458 (Registry Identifier)
CCCWFU 98214 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Supportive Care (pulsed dye laser)
Experimental group
Description:
Patients undergo pulsed dye laser monthly for three months.
Treatment:
Other: questionnaire administration
Procedure: laser therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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