NCT00592319 · REGISTRY CONDITION SEARCH

Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2012-08-31

Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical removal is the current management for RRP, but it is a very traumatic procedure, and often leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Time Course (Month) With Papilloma Recurrence During 12-month Follow up

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outcome · POSTED

Number of Case With Papilloma Recurrence During a 12-month Follow up

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. 18 to 64 years of age 2. with laryngeal papillomas requiring surgical treatment 3. willingness to participate in the study 4. a signed informed consent form Exclusion Criteria: 1. age less than 18 years 2. evidence of mental impairment so that the patient can not understand or sign the consent form 3. malignant diseases such as laryngeal cancer 4. established coronary heart and artery disorder, cerebrovascular disease, and other cardiovascular diseases 5. established diabetes, which requires (1) insulin treatment; or (2) more than 2 oral agents of medication; or (3) to have a baseline HgbA1c \>8.0 6. hypertension, with ongoing blood pressure \> 150 mg Hg systolic or to require medication 7. family history with serious cardiovascular events and problems 8. any sign and evidence which in the opinion of cardiovascular physician warrants exclusion of subject
healthy Volunteers: false
maximum Age: 64 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT

Treatment arms and interventions

arm Groups

description
endoscopic treatment with once-time PDL radiation at 6.0-8.0 J on laryngeal papilloma, followed by oral taking of 9-month Celebrex (100mg, BID), in 15 subjects
intervention Names
Drug: Celebrex
Device: PDL
label
PDL+Celebrex
type
EXPERIMENTAL
description
once-time and routine surgery, with either of carbon dioxide (CO2) laser radiation at 10.0-20.0 W or "cold" surgery with microinstruments, in 15 subjects
intervention Names
Procedure: CO2 laser or microsurgery
label
standard surgery
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
PDL+Celebrex
description
oral taking of Celebrex (100 mg, BID) for 9 months
name
Celebrex
other Names
Celecoxib
type
DRUG
arm Group Labels
PDL+Celebrex
description
once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
name
PDL
other Names
585 nm PDL (cynosure Inc. Mass)
type
DEVICE
arm Group Labels
standard surgery
description
once-time surgery to remove laryngeal papilloma
name
CO2 laser or microsurgery
other Names
ablation laser or micro-instrumental surgery
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 10
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Criteria for the recurrence: the site scoring \>4, plus visible lesion found in \>50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.
measure
Number of Case With Papilloma Recurrence During a 12-month Follow up
time Frame
12-month follow up

secondary Outcomes

description
The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.
measure
Time Course (Month) With Papilloma Recurrence During 12-month Follow up
time Frame
12 months

Full study description

brief Summary: Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical removal is the current management for RRP, but it is a very traumatic procedure, and often leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP.
detailed Description: RRP and its surgeries usually involves the vocal cords or other regions of the larynx, thereby, resulting in a poor voice. Our previous studies have shown the efficacy and safety of a microvascular targeting technique (MVT) for RRP treatment using the 585 nm PDL. This technique provides a less traumatic alternative to surgery. However, postoperative recurrence of lesions still remains a problem because of microvascular regrowth. This study is a continuation of our effort to develop a new and less traumatic treatment for RRP. In this study, we will develop a new, combined RRP treatment with PDL and Celebrex. We will determine if Celebrex, a newly developed inhibitor of COX-2, can provide a long-term inhibitory effect on RRP through its anti-angiogenic activity and the synergic effect produced with the laser therapy. The hypothesis is that postoperative administration of Celebrex will provide a long-term inhibitory effect on microvascular regrowth and on COX-2 enzyme, thereby, preventing RRP from recurring after the PDL therapy. Our specific aim in this study is to determine the synergic effect between PDL and Celebrex and long-term efficacy of Celecoxib in preventing postoperative RRP recurrence. We will compare this new combined strategy with traditional treatments in 30 adult patients. This is the first time to combined this new laser MVT technique with a COX-2 inhibitor for microvascular targeting therapy of RRP. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP and will be safe and convenient enough for use in out-patient treatment.

Source references

Source notices and limitations

Discovery and provenance

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exact text
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offset unit
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query cond
Laryngeal Cancer
query disease state id
ds-laryngeal-cancer
source file
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice