New Therapy of Laryngeal Papilloma In Children

Papilloma Clinical Trial

Official title:

Voice Preserving Therapy of Laryngeal Papilloma In Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00591305
• Other study ID #: RDC-008287A
• Secondary ID: 5R01DC008287
• Status: Terminated
• Phase: N/A
• First received: December 31, 2007
• Last updated: May 16, 2017
• Start date: September 2007
• Est. completion date: October 2011

Study information

• Verified date: May 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Papilloma

Intervention

Dietary Supplement:
• diindolylmethane (DIM)
3-month DIM

Device:
• 585 nm pulsed dye laser
once-time PDL

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

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