New Therapy of Laryngeal Papilloma In Children

Study Overview
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Brief Summary
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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.

Detailed Description
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Previous studies have demonstrated that PDL can be used to remove lesions on the vocal cords and elsewhere in the throat causing less damage to surface tissues than other commonly used lasers. In our proposed clinical study, we seek to compare treatment efficacy for RRP by combining PDL with DIM, versus PDL-only treatment, in a total of 30 children with laryngeal papilloma. We will determine whether this combined treatment would be effective and safe in preventing or delaying the RRP recurrence while preserving voice quality. 30 children will be divided randomly into two treatment groups, 15 in each. The experimental group will receive one-time PDL treatment, followed by 3-month oral administration of DIM and an additional 12 months with no treatment. The other group will be treated with PDL-only, as a control, and take a placebo pill for 3 months. All of the patients will be followed for a total of 15 months. We will compare lesion recurrence and laboratory tests between the two groups, to determine efficacy and safety of the new treatment. This is the first study to combine new PDL laser technique with DIM, to develop a new, voice-preserving and long-term effective method of managing laryngeal RRP in children.

Official Title
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Voice Preserving Therapy of Laryngeal Papilloma In Children

Conditions
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Papilloma

Intervention / Treatment
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* Dietary Supplement: diindolylmethane (DIM)
* Device: 585 nm pulsed dye laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10 to 21 years of age laryngeal papillomas requiring surgical treatment willingness to participate in the study a signed informed consent form by guardian or parent Exclusion Criteria: age less than 10 year old, or older than 21 year guardian or parent does not understand or can not sign the consent form malignant diseases such as laryngeal cancer history of being hypersensitive to cabbage or other cruciferous vegetables pregnancy

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: laser only vs laser+ a dietary agent (DIM)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDL+DIM pill<br>once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects | Dietary Supplement: diindolylmethane (DIM)<br>* 3-month DIM<br>Device: 585 nm pulsed dye laser<br>* once-time PDL<br>|
| Placebo Comparator: PDL+placebo pill<br>once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects | Device: 585 nm pulsed dye laser<br>* once-time PDL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estradiol Level in Blood Pre Treatment | determine side-effect by comparing Estradiol level in blood before and after treatment | Before treatment at baseline | 
| Estradiol Level in Blood Post Treatment | determine side-effect by comparing Estradiol level in blood before and after treatment | 5 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDL, papilloma, diindolylmethane, recurrence