Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia (NCT02198131) | Clinical Trial Compass
CompletedNot Applicable
Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia
United States9 participantsStarted 2009-10
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Videostroboscopy rates
Timeframe: Up to 6 months post-treatment
2
Change in Voice Handicap Index (VHI)-10 score
Timeframe: Baseline to 6 months post-treatment
3
Change in jitter
Timeframe: Baseline and at 6 months post-treatment
4
Voice quality using the patient self-assessment questionnaire
Timeframe: Up to 6 months post-treatment
5
Change in shimmer
Timeframe: Baseline and at 6 months post-treatment
6
Change in noise to harmonic ratio
Timeframe: Baseline and at 6 months post-treatment
7
Change in mean phonatory flow
Timeframe: Baseline and at 6 months post-treatment