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临床试验/NCT00591305
NCT00591305终止不适用

Voice Preserving Therapy of Laryngeal Papilloma In Children

Boston University2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

treatment to be selected based on a randomized number table, blinded to participants

入排标准

年龄范围
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months

时间窗: 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

次要结局

  • Estradiol Level in Blood Pre Treatment(Before treatment at baseline)
  • Estradiol Level in Blood Post Treatment(5 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhi Wang

Professor and Director

Boston University

研究点 (2)

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