New Therapy of Laryngeal Papilloma In Children

NCT00591305 | Terminated Results DMC

• 2 other identifiers: RDC-008287A5R01DC008287
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Papilloma

Keywords

papilloma; PDL; diindolylmethane; recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Estradiol Level in Blood Pre Treatment

  Before treatment at baseline

• Estradiol Level in Blood Post Treatment

  5 month

Study Arms (2)

PDL+DIM pill

EXPERIMENTAL

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

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

PDL+placebo pill

PLACEBO COMPARATOR

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

Device: 585 nm pulsed dye laser

Interventions

diindolylmethane (DIM) DIETARY_SUPPLEMENT

3-month DIM

PDL+DIM pill

585 nm pulsed dye laser DEVICE

once-time PDL

PDL+DIM pill; PDL+placebo pill

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Papilloma; Recurrence

Interventions

3,3'-diindolylmethane; Lasers, Dye

Condition Hierarchy (Ancestors)

Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Limitations and Caveats

There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.

Results Point of Contact

• Title: Zhi Wang, MD
• Organization: Boston Medical Center

zwang@bu.edu

617-414-1590

Study Officials

• Zhi Wang, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: treatment to be selected based on a randomized number table, blinded to participants
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Model Details: laser only vs laser+ a dietary agent (DIM)

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 11, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 18, 2017
• Results First Posted: May 18, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)