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Voice Preserving Therapy of Laryngeal Papilloma In Children

Phase 2
10 Years
21 Years
Not Enrolling

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Trial Information

Voice Preserving Therapy of Laryngeal Papilloma In Children

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Outcome Measure:

Recurrence of laryngeal papilloma

Outcome Time Frame:

At recurrance or 5 months

Safety Issue:


Principal Investigator

Zhi Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

October 2011

Related Keywords:

  • Papilloma
  • papilloma
  • PDL
  • diindolylmethane
  • recurrence
  • Papilloma



Boston Medical Center Boston, Massachusetts  02118