PapillomaNCT00591305
New Therapy of Laryngeal Papilloma In Children
A study testing diindolylmethane (DIM) and 585 nm pulsed dye laser in people with Papilloma, run by Boston University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Papilloma
- What is being tested?
- diindolylmethane (DIM) and 585 nm pulsed dye laser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 10 to 21 years of age
- laryngeal papillomas requiring surgical treatment
- willingness to participate in the study
- a signed informed consent form by guardian or parent
Who cannot join
- age less than 10 year old, or older than 21 year
- guardian or parent does not understand or can not sign the consent form
- malignant diseases such as laryngeal cancer
- history of being hypersensitive to cabbage or other cruciferous vegetables
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voice Preserving Therapy of Laryngeal Papilloma In Children
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.
Read the 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.
- Conditions
- Papilloma
- Being tested
- diindolylmethane (DIM), 585 nm pulsed dye laser
- Keywords
- papilloma, PDL, diindolylmethane, recurrence
- Medical subject headings
- Papilloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diindolylmethane (DIM)Dietary supplement
3-month DIM
585 nm pulsed dye laserDevice
once-time PDL
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: diindolylmethane (DIM); Device: 585 nm pulsed dye laser |
| 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 Receives: Device: 585 nm pulsed dye laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Recurrence of pailloma at 5 months
Secondary outcomes (2)
Estradiol Level in Blood Pre Treatment
determine side-effect by comparing Estradiol level in blood before and after treatment
Measured: Before treatment at baseline
Estradiol Level in Blood Post Treatment
determine side-effect by comparing Estradiol level in blood before and after treatment
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2011
- Study completionOct 2011
Why it stopped: insufficient resource for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PapillomaStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- laser only vs laser+ a dietary agent (DIM)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Zhi Wang, Boston University
- Investigators
- Zhi Wang, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591305
- Sponsor's protocol ID
- RDC-008287A
- Other IDs
- 5R01DC008287
- Status last verified
- May 2017
- First submitted
- 31 Dec 2007
- Last updated
- 18 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: no such meaningful data available due to insufficient recruitment
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Preserving Therapy of Laryngeal Papilloma In Children
- ClinicalTrials.gov ID
- NCT00591305
- Acronym / sponsor ID
- RDC-008287A
- Conditions
- Papilloma
- Keywords
- papilloma, PDL, diindolylmethane, recurrence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient resource for recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Sep 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- laser only vs laser+ a dietary agent (DIM)
| Arm | Type | Receives |
|---|---|---|
| PDL+DIM pill | Experimental | Dietary Supplement: diindolylmethane (DIM), Device: 585 nm pulsed dye laseronce-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 | Device: 585 nm pulsed dye laseronce-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 10 to 21 years of age
- laryngeal papillomas requiring surgical treatment
- willingness to participate in the study
- a signed informed consent form by guardian or parent
Key exclusion criteria (5 listed)
- age less than 10 year old, or older than 21 year
- guardian or parent does not understand or can not sign the consent form
- malignant diseases such as laryngeal cancer
- history of being hypersensitive to cabbage or other cruciferous vegetables
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diindolylmethane (DIM)3-month DIM | Dietary supplement | PDL+DIM pill |
| 585 nm pulsed dye laseronce-time PDL | Device | PDL+DIM pill, PDL+placebo pill |
Primary outcome
Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months
Time frame: 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
2 secondary outcomes
Estradiol Level in Blood Pre Treatment
Time frame: Before treatment at baseline
Estradiol Level in Blood Post Treatment
Time frame: 5 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. no such meaningful data available due to insufficient recruitment
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Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)
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A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi Wang, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diindolylmethane (DIM) and 585 nm pulsed dye laser in people with Papilloma, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months (time frame: Recurrence of pailloma at 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.