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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DC008287 | U.S. NIH Grant/Contract | View source |
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insufficient resource for recruitment
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDL+DIM pill | Experimental | 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 |
|
| PDL+placebo pill | Placebo Comparator | once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diindolylmethane (DIM) | Dietary Supplement | 3-month DIM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Recurrence of pailloma at 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estradiol Level in Blood Pre Treatment | determine side-effect by comparing Estradiol level in blood before and after treatment | Before treatment at baseline |
| Estradiol Level in Blood Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhi Wang, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
no such meaningful data available due to insufficient recruitment
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There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.
5 month follow up study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | PDL+Placebo Pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | participants received at least one of two interventions | Posted | Number | case | Recurrence of pailloma at 5 months |
|
3 months after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhi Wang, MD | Boston Medical Center | 617-414-1590 | zwang@bu.edu |
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| ID | Term |
|---|---|
| D010212 | Papilloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D018307 | Neoplasms, Squamous Cell |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C016392 | 3,3'-diindolylmethane |
| D054025 | Lasers, Dye |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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laser only vs laser+ a dietary agent (DIM)
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treatment to be selected based on a randomized number table, blinded to participants
| 585 nm pulsed dye laser |
| Device |
once-time PDL |
|
determine side-effect by comparing Estradiol level in blood before and after treatment
| 5 month |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Estradiol Level in Blood Pre Treatment | determine side-effect by comparing Estradiol level in blood before and after treatment | failure for any meaningful analysis as only 1 participant in this study | Posted | Number | pg/ml | Before treatment at baseline |
|
|
|
| Secondary | Estradiol Level in Blood Post Treatment | determine side-effect by comparing Estradiol level in blood before and after treatment | failure for any meaningful analysis as only 1 participant in this study | Posted | Number | pg/ml | 5 month |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | PDL+Placebo Pill | once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects | 0 | 0 | 0 | 0 | 0 | 0 |
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |