Oral Complications of Radiation TherapyNCT02198131
Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia
A study testing laser therapy and questionnaire administration in people with Oral Complications of Radiation Therapy and Stage I Laryngeal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Complications of Radiation Therapy, Stage I Laryngeal Cancer, Stage II Laryngeal Cancer
- What is being tested?
- laser therapy and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Pulsed Dye Laser for Treatment of 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Oral Complications of Radiation Therapy, Stage I Laryngeal Cancer, Stage II Laryngeal Cancer
- Being tested
- laser therapy, questionnaire administration
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapyProcedure or surgery
Also called therapy, laser
Undergo pulsed dye laser
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (pulsed dye laser) | Experimental | Patients undergo pulsed dye laser monthly for three months. Receives: Procedure: laser therapy; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Videostroboscopy rates
Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.
Measured: 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.
Measured: Baseline to 6 months post-treatment
Change in jitter
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Measured: 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.
Measured: Up to 6 months post-treatment
Change in shimmer
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Measured: 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.
Measured: 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.
Measured: Baseline and at 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startOct 2009
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Complications of Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carter Wright, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198131
- Sponsor's protocol ID
- IRB00011092
- Other IDs
- NCI-2014-01458, CCCWFU 98214, P30CA012197
- Status last verified
- Apr 2023
- First submitted
- 21 Jul 2014
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Dye Laser for Treatment of Post Radiation Dysphonia
- ClinicalTrials.gov ID
- NCT02198131
- Acronym / sponsor ID
- IRB00011092
- Conditions
- Oral Complications of Radiation Therapy, Stage I Laryngeal Cancer, Stage II Laryngeal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2009
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (pulsed dye laser) | Experimental | Procedure: laser therapy, Other: questionnaire administrationPatients undergo pulsed dye laser monthly for three months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser therapyAlso: therapy, laserUndergo pulsed dye laser | Procedure or surgery | Supportive Care (pulsed dye laser) |
| questionnaire administrationAncillary studies | Other | Supportive Care (pulsed dye laser) |
Primary outcome
Videostroboscopy rates
Time frame: Up to 6 months post-treatment
Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carter Wright principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy and questionnaire administration in people with Oral Complications of Radiation Therapy and Stage I Laryngeal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Videostroboscopy rates (time frame: Up to 6 months post-treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.