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

NCT05688488 | Recruiting Phase 1

• 1 other identifier: 2022011-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glottic Web of Larynx; Laryngeal Stenosis; Glottic Carcinoma; Laryngeal Leucoplakia; Laryngeal Polyp; Laryngeal Papilloma

Keywords

Curcumin

Outcome Measures

Primary Outcomes (1)

• Number of participants with laryngeal web formation as assessed by videolaryngoscope

  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.

  1 year postsurgery

Study Arms (2)

Curcumin

EXPERIMENTAL

Drug: Curcumin

Mitomycin

ACTIVE COMPARATOR

Drug: Mitomycin-C

Interventions

Curcumin DRUG

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.

Curcumin

Mitomycin-C DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bilateral vocal cord diseases who are going to undergo resection of bilateral vocal cord lesions endoscopically.
• Patients with bilateral vocal cord adhesion who are going to undergo incision of bilateral vocal cord adhesion endoscopically.

You may not qualify if:

• Patients with other laryngeal diseases.
• Patients with cardiac and pulmonary insufficiency.
• Patients unable to cooperate with the follow-up on time after surgery.
• Patients who refuse to sign the informed consent after notification.
• Patients who have a severe allergic disease or allergic history to a variety of drugs.
• Other circumstances that are not appropriate to be included in the clinical trial.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Laryngostenosis; Laryngeal papillomatosis

Interventions

Curcumin; Mitomycin

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Mitomycins; Indolequinones; Quinones; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Jian Chen, Ph.D

CONTACT

+8621-64377134; chenjent@qq.com

Haitao Wu, Ph.D

CONTACT

+8621-64377134; eentwuhaitao@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 18, 2023
• Study Start: May 5, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2023

Record last verified: 2023-01

Locations

CN (1)