TerminatedNot Applicable

New Therapy of Laryngeal Papilloma In Children

Stopped: insufficient resource for recruitment

United States1 participantsStarted 2007-09

Plain-language 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.

Who can participate

Age range10 Years – 21 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. pregnancy

What they're measuring

Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months

Timeframe: Recurrence of pailloma at 5 months

Trial details

NCT IDNCT00591305

SponsorBoston University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

Results submitted2017-02-24

View on ClinicalTrials.gov More Papilloma trials