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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01458 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 98214 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (pulsed dye laser) | Experimental | Patients undergo pulsed dye laser monthly for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laser therapy | Procedure | Undergo pulsed dye laser |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carter Wright | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| questionnaire administration | Other | Ancillary studies |
|
| Baseline and at 6 months post-treatment |
| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |