NCT00591305 · REGISTRY CONDITION SEARCH

New Therapy of Laryngeal Papilloma In Children

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2017-05-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months

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outcome · POSTED

Estradiol Level in Blood Pre Treatment

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outcome · POSTED

Estradiol Level in Blood Post Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 21 Years
minimum Age: 10 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

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
intervention Names
Dietary Supplement: diindolylmethane (DIM)
Device: 585 nm pulsed dye laser
label
PDL+DIM pill
type
EXPERIMENTAL
description
once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
intervention Names
Device: 585 nm pulsed dye laser
label
PDL+placebo pill
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
PDL+DIM pill
description
3-month DIM
name
diindolylmethane (DIM)
type
DIETARY_SUPPLEMENT
arm Group Labels
PDL+DIM pill
PDL+placebo pill
description
once-time PDL
name
585 nm pulsed dye laser
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

laser only vs laser+ a dietary agent (DIM)

masking Info

masking: SINGLE
masking Description: treatment to be selected based on a randomized number table, blinded to participants
who Masked: PARTICIPANT

primary Purpose

PREVENTION

Enrollment

count: 1
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
vocal lesion size and area after 5 month with surgery visible lesion found in \>50% of the treated tissue area, after surgery
measure
Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months
time Frame
Recurrence of pailloma at 5 months

secondary Outcomes

description
determine side-effect by comparing Estradiol level in blood before and after treatment
measure
Estradiol Level in Blood Pre Treatment
time Frame
Before treatment at baseline
description
determine side-effect by comparing Estradiol level in blood before and after treatment
measure
Estradiol Level in Blood Post Treatment
time Frame
5 month

Full study description

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 Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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exact text
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offset unit
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query cond
Laryngeal Cancer
query disease state id
ds-laryngeal-cancer
source file
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source kind
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice