New Therapy of Laryngeal Papilloma In Children

Voice Preserving Therapy of Laryngeal Papilloma In Children

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.

Study Overview

• Status: Terminated
• Conditions: Papilloma
• Intervention / Treatment: Dietary supplement: diindolylmethane (DIM); Device: 585 nm pulsed dye laser

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: diindolylmethane (DIM); 3-month DIM; Device: 585 nm pulsed dye laser; once-time PDL
Placebo Comparator: PDL+placebo pill; 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; once-time PDL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estradiol Level in Blood Pre Treatment	determine side-effect by comparing Estradiol level in blood before and after treatment	Before treatment at baseline
Estradiol Level in Blood Post Treatment	determine side-effect by comparing Estradiol level in blood before and after treatment	5 month

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Zhi Wang, MD, Boston University

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: December 31, 2007
• First Submitted That Met QC Criteria: January 10, 2008
• First Posted (Estimate): January 11, 2008

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: recurrence; papilloma; PDL; diindolylmethane
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; 3,3'-diindolylmethane
• Other Study ID Numbers: RDC-008287A; 5R01DC008287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no such meaningful data available due to insufficient recruitment