New Therapy of Laryngeal Papilloma In Children

NCT ID: NCT00591305

Last Updated: 2017-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-10-31

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.

Conditions

Papilloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PDL+DIM pill

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

Group Type: EXPERIMENTAL

diindolylmethane (DIM)

Intervention Type: DIETARY_SUPPLEMENT

3-month DIM

585 nm pulsed dye laser

Intervention Type: DEVICE

once-time PDL

PDL+placebo pill

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

Group Type: PLACEBO_COMPARATOR

585 nm pulsed dye laser

Intervention Type: DEVICE

once-time PDL

Interventions

diindolylmethane (DIM)

3-month DIM

Intervention Type: DIETARY_SUPPLEMENT

585 nm pulsed dye laser

once-time PDL

Intervention Type: DEVICE

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Zhi Wang

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

5R01DC008287

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RDC-008287A

Identifier Type: -

Identifier Source: org_study_id