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New Therapy of Laryngeal Papilloma In Children

This study has been terminated.
(insufficient resource for recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00591305
First Posted: January 11, 2008
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Zhi Wang, Boston University
  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
Papilloma Dietary Supplement: diindolylmethane (DIM) Device: 585 nm pulsed dye laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
laser only vs laser+ a dietary agent (DIM)
Masking: Single (Participant)
Masking Description:
treatment to be selected based on a randomized number table, blinded to participants
Primary Purpose: Prevention
Official Title: Voice Preserving Therapy of Laryngeal Papilloma In Children

Further study details as provided by Zhi Wang, Boston University:

Primary Outcome Measures:
  • Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months [ Time Frame: Recurrence of pailloma at 5 months ]
    vocal lesion size and area after 5 month with surgery visible lesion found in >50% of the treated tissue area, after surgery


Secondary Outcome Measures:
  • Estradiol Level in Blood Pre Treatment [ Time Frame: Before treatment at baseline ]
    determine side-effect by comparing Estradiol level in blood before and after treatment

  • Estradiol Level in Blood Post Treatment [ Time Frame: 5 month ]
    determine side-effect by comparing Estradiol level in blood before and after treatment


Enrollment: 1
Study Start Date: September 2007
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591305


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Zhi Wang, MD Boston University
  More Information

Responsible Party: Zhi Wang, Professor and Director, Boston University
ClinicalTrials.gov Identifier: NCT00591305     History of Changes
Other Study ID Numbers: RDC-008287A
5R01DC008287 ( U.S. NIH Grant/Contract )
First Submitted: December 31, 2007
First Posted: January 11, 2008
Results First Submitted: February 24, 2017
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no such meaningful data available due to insufficient recruitment

Keywords provided by Zhi Wang, Boston University:
papilloma
PDL
diindolylmethane
recurrence

Additional relevant MeSH terms:
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms