NCT07492654

Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream

Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream: An Open-label, Multicenter, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical trial is to understand whether triethanolamine cream can prevent and treat acute radiation vaginitis. It will also learn about the safety of triethanolamine cream. The main questions it aims to answer include: Can triethanolamine cream reduce the incidence and severity of radiation vaginitis in cervical cancer patients undergoing radiotherapy? What medical problems might participants encounter when using triethanolamine cream? Researchers will compare triethanolamine cream with routine care to observe whether triethanolamine cream will reduce the incidence and severity of radiation vaginitis in cervical cancer patients receiving radiotherapy. Participants will: Daily vaginal administration of triethanolamine cream, vaginal opening application and routine care, or only routine care, from the first day of radiotherapy until 28 days after the end of radiotherapy. Four examinations were conducted respectively from before radiotherapy to 90 days after its end. Record their symptoms and conduct injury scoring.

Conditions

• Vaginitis
• Radiotherapy Induced Mucositis

Interventions

Type	Name	Description
DRUG	Trolamine (Biafine)	After radiotherapy every day, on the basis of regular medication and care, apply a standard dose of 4ml of Trolamine cream into the vagina using a uniform model vaginal delivery device (for patients with significant vaginal volume abnormalities, increase or decrease as appropriate, but the deviation should not exceed 30% of the standard dose), and fully apply it to the vaginal opening twice a day

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2026-03-25
• Last updated: 2026-03-25