Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Papilloma

Laryngeal Neoplasms

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Laryngeal Papillomatosis

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

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

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

oral taking of Celebrex (100 mg, BID) for 9 months

Celebrex

once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J

once-time surgery to remove laryngeal papilloma

CO2 laser or microsurgery

Wang Zhi, M.D

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.

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.

Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Voice-preserving Treatment of Laryngeal Papilloma

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.

The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.

National Institute on Deafness and Other Communication Disorders (NIDCD)

Boston University

Professor and Director

Others: laser and surgery complications for 12 months

Experiment

Control

treated with routine surgery (CO2 laser or "cold" microsurgery), in 15 cases

treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases

Experimental

Total

Age, Categorical

Sex: Female, Male

We failed to recruit a total of 30 cases, due to (1) This disease is relative less common in clinic; and (2) particularly, more and more of patients now had a serious concern in safety of Celebrex due to news and warnings to public in recent years.

Dr. Zhi Wang

treated with both of once-time PDL and 9-month Celebrex

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

treated with once-time routine surgery (CO2 laser or "cold" microsurgery)

treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months

Experienment

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.

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

once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or "cold" surgery with micro-instruments), in 15 subjects

once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months

Overall Study

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Carcinoma

Tissue Adhesions

Constriction, Pathologic

Polyps

Leukoplakia

Laryngostenosis

Precancerous Conditions

Pathological Conditions, Anatomical

Congenital Abnormalities

Respiratory System Abnormalities

Antineoplastic Agents

Anti-Infective Agents

Curcumin

Mitomycins

Mitomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Curcumin was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.

Mitomycin-C was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.

Mitomycin-C

Jian Chen, Ph.D

Haitao Wu, Ph.D

Jian Chen

To provide a novel therapy idea and method to solve the clinical problem of postoperative adhesion of bilateral vocal cords, patients enrolled in this study will be applied with curcumin on both wound sites of bilateral vocal cords after the surgery on the bilateral vocal cord endoscopically.

Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

All participants received the videolaryngoscope every month post-surgery, and a laryngeal web is defined as a visible adhesion whose length reached 1 mm or greater.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Celebrex (Celecoxib) Treatment of Laryngeal Papilloma	NCT00592319	Laryngeal Papil...	Celebrex PDL CO2 laser or mi...	18 Years - 64 Years	Boston University
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords	NCT05688488	Glottic Web of ... Laryngeal Steno... Glottic Carcino... Laryngeal Leuco... Laryngeal Polyp Laryngeal Papil...	Curcumin Mitomycin-C	18 Years - 75 Years	Eye & ENT Hospital of Fudan University

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