Papilloma Clinical Trial
Official title:
Voice Preserving Therapy of Laryngeal Papilloma In Children
Verified date | May 2017 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will determine efficacy of a new and combined treatment of laryngeal recurrent respiratory papillomatosis (RRP), by using a 585 nm pulsed dye laser (PDL) and a dietary supplement, diindolylmethane (DIM). We will compare this new treatment with PDL-only, in a total of 30 children (15 of each treatment), to determine whether this combined treatment would be effective and safe in preventing the RRP recurrence. This is the first study to combine PDL technique with DIM, to develop a new, voice-preserving and long-term effective method of managing laryngeal RRP in children.
Status | Terminated |
Enrollment | 1 |
Est. completion date | October 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 21 Years |
Eligibility |
Inclusion Criteria: 1. 10 to 21 years of age 2. laryngeal papillomas requiring surgical treatment 3. willingness to participate in the study 4. a signed informed consent form by guardian or parent Exclusion Criteria: 1. age less than 10 year old, or older than 21 year 2. guardian or parent does not understand or can not sign the consent form 3. malignant diseases such as laryngeal cancer 4. history of being hypersensitive to cabbage or other cruciferous vegetables 5. pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months | vocal lesion size and area after 5 month with surgery visible lesion found in >50% of the treated tissue area, after surgery | Recurrence of pailloma at 5 months | |
Secondary | Estradiol Level in Blood Pre Treatment | determine side-effect by comparing Estradiol level in blood before and after treatment | Before treatment at baseline | |
Secondary | Estradiol Level in Blood Post Treatment | determine side-effect by comparing Estradiol level in blood before and after treatment | 5 month |
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