New Therapy of Laryngeal Papilloma In Children

• Sponsor: Boston University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00591305
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 1
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Papilloma	Dietary Supplement: diindolylmethane (DIM); Device: 585 nm pulsed dye laser	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: laser only vs laser+ a dietary agent (DIM)laser only vs laser+ a dietary agent (DIM)
• Masking: Single (Participant)
• Masking Description: treatment to be selected based on a randomized number table, blinded to participants
• Primary Purpose: Prevention
• Official Title: Voice Preserving Therapy of Laryngeal Papilloma In Children
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Dietary Supplement: diindolylmethane (DIM); 3-month DIM; Device: 585 nm pulsed dye laser; once-time PDL
Placebo Comparator: PDL+placebo pill once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects	Device: 585 nm pulsed dye laser; once-time PDL

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Estradiol Level in Blood Pre Treatment [Before treatment at baseline]

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

2. Estradiol Level in Blood Post Treatment [5 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston University
• National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: Zhi Wang, MD, Boston University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhi Wang, Professor and Director, Boston University
• ClinicalTrials.gov Identifier: NCT00591305
• Other Study ID Numbers: RDC-008287A; 5R01DC008287
• First Posted: Jan 11, 2008
• Last Update Posted: May 18, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Zhi Wang, Professor and Director, Boston University: papilloma; PDL; diindolylmethane; recurrence
• Additional relevant MeSH terms: Papilloma; 3,3'-diindolylmethane

Study Results

Participant Flow

Recruitment Details	5 month follow up study
Pre-assignment Detail	There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.

Arm/Group Title	PDL+DIM Pill	PDL+Placebo Pill
Arm/Group 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 diindolylmethane (DIM): 3-month DIM 585 nm pulsed dye laser: once-time PDL	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
Period Title: Overall Study
STARTED	1	0
1st Follow-up in 2 Wks After Surgery	1	0
COMPLETED	1	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	PDL+DIM Pill	PDL+Placebo Pill	Total
Arm/Group 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 diindolylmethane (DIM): 3-month DIM 585 nm pulsed dye laser: once-time PDL	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 of all reporting groups
Overall Participants	1	0	1
Age (Count of Participants)
<=18 years	1 100%	0 NaN	1 100%
Between 18 and 65 years	0 0%	0 NaN	0 0%
>=65 years	0 0%	0 NaN	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN	0 0%
Male	1 100%	0 NaN	1 100%
Region of Enrollment (participants) [Number]
United States	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months
Description	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

Outcome Measure Data

Analysis Population Description

participants received at least one of two interventions

Arm/Group Title	Intervention	Placebo
Arm/Group Description	laser+dietary DIM	laser only without DIM
Measure Participants	1	0
Number [case]	1

2. Secondary Outcome

Title	Estradiol Level in Blood Pre Treatment
Description	determine side-effect by comparing Estradiol level in blood before and after treatment
Time Frame	Before treatment at baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intervention	Placebo
Arm/Group Description	laser+diatary DIM	laser only without DIM
Measure Participants	1	0
Number [pg/ml]	20

3. Secondary Outcome

Title	Estradiol Level in Blood Post Treatment
Description	determine side-effect by comparing Estradiol level in blood before and after treatment
Time Frame	5 month

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intervention	Placebo
Arm/Group Description	laser+diatary DIM	laser only without DIM
Measure Participants	1	0
Number [pg/ml]	29

Adverse Events

Time Frame	3 months after surgery
Arm/Group Title	PDL+DIM Pill		PDL+Placebo Pill
Arm/Group 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		once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
All Cause Mortality
	PDL+DIM Pill		PDL+Placebo Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Serious Adverse Events
	PDL+DIM Pill		PDL+Placebo Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	PDL+DIM Pill		PDL+Placebo Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.