Clinical trial NCT00591305: New Therapy of Laryngeal Papilloma In Children
Official title: Voice Preserving Therapy of Laryngeal Papilloma In Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Papilloma
Keywords: papilloma
PDL
diindolylmethane
recurrence
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2008-01-11
Enrollment: 1
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: laser only vs laser+ a dietary agent (DIM)
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months
timeFrame: Recurrence of pailloma at 5 months
Secondary outcomes:
measure: Estradiol Level in Blood Pre Treatment
timeFrame: Before treatment at baseline
measure: Estradiol Level in Blood Post Treatment
timeFrame: 5 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Zhi Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: