Papilloma
Conditions
Keywords
papilloma, PDL, diindolylmethane, recurrence
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.
Interventions
DIETARY_SUPPLEMENTdiindolylmethane (DIM)
3-month DIM
DEVICE585 nm pulsed dye laser
once-time PDL
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
treatment to be selected based on a randomized number table, blinded to participants
Intervention model description
laser only vs laser+ a dietary agent (DIM)
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estradiol Level in Blood Pre Treatment | Before treatment at baseline | determine side-effect by comparing Estradiol level in blood before and after treatment |
| Estradiol Level in Blood Post Treatment | 5 month | determine side-effect by comparing Estradiol level in blood before and after treatment |
Countries
United States
Participant flow
Recruitment details
5 month follow up study
Pre-assignment details
There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.
Participants by arm
| Arm | Count |
|---|---|
| PDL+DIM Pill 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
diindolylmethane (DIM): 3-month DIM
585 nm pulsed dye laser: once-time PDL | 1 |
| PDL+Placebo Pill once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
585 nm pulsed dye laser: once-time PDL | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | PDL+DIM Pill | PDL+Placebo Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | — | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months
vocal lesion size and area after 5 month with surgery visible lesion found in \>50% of the treated tissue area, after surgery
Time frame: Recurrence of pailloma at 5 months
Population: participants received at least one of two interventions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months | 1 case |
Secondary
Estradiol Level in Blood Post Treatment
determine side-effect by comparing Estradiol level in blood before and after treatment
Time frame: 5 month
Population: failure for any meaningful analysis as only 1 participant in this study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Estradiol Level in Blood Post Treatment | 29 pg/ml |
Secondary
Estradiol Level in Blood Pre Treatment
determine side-effect by comparing Estradiol level in blood before and after treatment
Time frame: Before treatment at baseline
Population: failure for any meaningful analysis as only 1 participant in this study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Estradiol Level in Blood Pre Treatment | 20 pg/ml |