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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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