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

Glottic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688488
• Other study ID #: 2022011-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 5, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Jian Chen, Ph.D
• Phone: +8621-64377134
• Email: chenjent[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

2. Patients with bilateral vocal cord adhesion who are going to undergo incision of bilateral vocal cord adhesion endoscopically.

Exclusion Criteria:

1. Patients with other laryngeal diseases.

2. Patients with cardiac and pulmonary insufficiency.

3. Patients unable to cooperate with the follow-up on time after surgery.

4. Patients who refuse to sign the informed consent after notification.

5. Patients who have a severe allergic disease or allergic history to a variety of drugs.

6. Other circumstances that are not appropriate to be included in the clinical trial.

Related Conditions & MeSH terms

• Glottic Carcinoma
• Laryngeal Papilloma
• Laryngeal Stenosis
• Laryngostenosis
• Leukoplakia
• Papilloma

Intervention

Drug:
• Curcumin
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
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.

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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