Trial Outcomes & Findings for New Therapy of Laryngeal Papilloma In Children (NCT NCT00591305)

Results Overview

vocal lesion size and area after 5 month with surgery visible lesion found in \>50% of the treated tissue area, after surgery

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Recurrence of pailloma at 5 months

Results posted on

2017-05-18

Participant Flow

5 month follow up study

There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	1	0
Overall Study 1st Follow-up in 2 Wks After Surgery	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

New Therapy of Laryngeal Papilloma In Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PDL+DIM Pill n=1 Participants 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	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	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Recurrence of pailloma at 5 months

Population: participants received at least one of two interventions

vocal lesion size and area after 5 month with surgery visible lesion found in \>50% of the treated tissue area, after surgery

Outcome measures

Outcome measures
Measure	Intervention n=1 Participants laser+dietary DIM	Placebo laser only without DIM
Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months	1 case	—

SECONDARY outcome

Timeframe: Before treatment at baseline

Population: failure for any meaningful analysis as only 1 participant in this study

determine side-effect by comparing Estradiol level in blood before and after treatment

Outcome measures

Outcome measures
Measure	Intervention n=1 Participants laser+dietary DIM	Placebo laser only without DIM
Estradiol Level in Blood Pre Treatment	20 pg/ml	—

SECONDARY outcome

Timeframe: 5 month

Population: failure for any meaningful analysis as only 1 participant in this study

determine side-effect by comparing Estradiol level in blood before and after treatment

Outcome measures

Outcome measures
Measure	Intervention n=1 Participants laser+dietary DIM	Placebo laser only without DIM
Estradiol Level in Blood Post Treatment	29 pg/ml	—

Adverse Events

PDL+DIM Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PDL+Placebo Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zhi Wang, MD

Boston Medical Center

Phone: 617-414-1590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place