Laryngeal Papilloma
Conditions
Keywords
Papilloma, pulsed dye laser, Celebrex, voice
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.
Interventions
DRUGCelebrex
oral taking of Celebrex (100 mg, BID) for 9 months
DEVICEPDL
once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
PROCEDURECO2 laser or microsurgery
once-time surgery to remove laryngeal papilloma
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Case With Papilloma Recurrence During a 12-month Follow up | 12-month follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Course (Month) With Papilloma Recurrence During 12-month Follow up | 12 months | The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence. |
Countries
United States
Participant flow
Recruitment details
3 years
Pre-assignment details
Many patients, who were eligible for this study, finally declined to participate this study due to a safety concern with Celebrex
Participants by arm
| Arm | Count |
|---|---|
| Control treated with routine surgery (CO2 laser or cold microsurgery), in 15 cases | 2 |
| Experimental treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases | 8 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 8 Participants | 10 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 2 |
| serious Total, serious adverse events | 0 / 8 | 0 / 2 |
Outcome results
Primary
Number of Case With Papilloma Recurrence During a 12-month Follow up
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.
Time frame: 12-month follow up
Population: The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Case With Papilloma Recurrence During a 12-month Follow up | 2 case |
| Experiment | Number of Case With Papilloma Recurrence During a 12-month Follow up | 5 case |
Secondary
Time Course (Month) With Papilloma Recurrence During 12-month Follow up
The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.
Time frame: 12 months
Population: 12-month follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Time Course (Month) With Papilloma Recurrence During 12-month Follow up | 3.5 month |
| Experiment | Time Course (Month) With Papilloma Recurrence During 12-month Follow up | 5.2 month |