New Therapy of Laryngeal Papilloma In Children

Boston University

Status: Terminated

Conditions: Papilloma

Treatments: Device: 585 nm pulsed dye laser; Dietary Supplement: diindolylmethane (DIM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00591305

RDC-008287A

5R01DC008287 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups, including a placebo group

PDL+DIM pill

Experimental group

Description:

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

Treatment:

Device: 585 nm pulsed dye laser

Dietary Supplement: diindolylmethane (DIM)

PDL+placebo pill

Placebo Comparator group

Description:

once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects

Treatment:

Device: 585 nm pulsed dye laser