Clinical trial · Interventional
New Therapy of Laryngeal Papilloma In Children
Voice Preserving Therapy of Laryngeal Papilloma In Children
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient resource for recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papilloma | Papilloma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 585 nm pulsed dye laser | Device | — | UNRESOLVED |
| diindolylmethane (DIM) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PDL+DIM pill
- description
- 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
- interventionNames
- Dietary Supplement: diindolylmethane (DIM)
- Device: 585 nm pulsed dye laser
- type
- PLACEBO_COMPARATOR
- label
- PDL+placebo pill
- description
- once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
- interventionNames
- Device: 585 nm pulsed dye laser
Primary outcomes (1)
- measure
- Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available