Clinical Trial: New Therapy of Laryngeal Papilloma In Children

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Voice Preserving Therapy of Laryngeal Papilloma In Children

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.

Detailed Summary: 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.
Sponsor: Boston University

Current Primary Outcome: 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


Original Primary Outcome: Recurrence of laryngeal papilloma [ Time Frame: At recurrance or 5 months ]

Current Secondary Outcome:

  • 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


Original Secondary Outcome: urine, blood and other laboratory tests [ Time Frame: 5 month ]

Information By: Boston University

Dates:
Date Received: December 31, 2007
Date Started: September 2007
Date Completion:
Last Updated: May 16, 2017
Last Verified: May 2017