New Therapy of Laryngeal Papilloma In Children - Full Text View

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:	NCT00591305

Purpose

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.

Condition	Intervention	Phase
Papilloma	Dietary Supplement: diindolylmethane (DIM) Device: 585 nm pulsed dye laser	Phase II

MedlinePlus related topics: Dietary Supplements Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Voice Preserving Therapy of Laryngeal Papilloma In Children

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Primary Outcome Measures:

Recurrence of laryngeal papilloma [ Time Frame: At recurrance or 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

urine, blood and other laboratory tests [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental once-time PDL, followed by 3-month oral taking DIM, in 15 subjects	Dietary Supplement: diindolylmethane (DIM) oral administration of DIM (to provide 1.2-1.75 mg DIM/Kg daily) for 3 months, with an additional 12 months of follow-up. Device: 585 nm pulsed dye laser once-time PDL for both of groups
2: Placebo Comparator once-time PDL, plus 3-month oral taking DIM placebo, in other 15 subjects	Device: 585 nm pulsed dye laser once-time PDL for both of groups

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

Ages Eligible for Study:	10 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

10 to 21 years of age
laryngeal papillomas requiring surgical treatment
willingness to participate in the study
a signed informed consent form by guardian or parent

Exclusion Criteria:

age less than 10 year old, or older than 21 year
guardian or parent does not understand or can not sign the consent form
malignant diseases such as laryngeal cancer
history of being hypersensitive to cabbage or other cruciferous vegetables
pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591305

Contacts

Contact: Pieter Noordzij, M.D

617-638-7933

pieter.noordzij@bmc.org

Locations

United States, Massachusetts
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Mary Zoccoli, MD 631-398-5652 mary.zoccoli@bmc.org

Sponsors and Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Zhi Wang, MD

Boston University

More Information

No publications provided

Responsible Party:	Trustess of Boston University ( Zhi Wang )
Study ID Numbers:	RDC-008287A
Study First Received:	December 31, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00591305 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

papilloma
PDL
diindolylmethane
recurrence

Study placed in the following topic categories:

Neoplasms, Squamous Cell
Papilloma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Papilloma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009