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

NCT07492654 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: BYFFL-02
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of radiation vaginitis

  The vaginal mucosa is routinely examined and scored by an independent gynecologist or radiologist (not related to the treatment implementing physician) using the acute-phase radiation vaginitis auxiliary grading template (i.e., based on the simplified VMMI) Classify the symptoms of radioactive vaginitis from mild to severe as "0 grade, 1 grade, 2 grade, 3 grade".

  "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"

Secondary Outcomes (5)

• Vaginal mucosal healing rate

  "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"

• EORTC Quality of Life Questionnaire (QLQ-CX24)

  "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"

• Vaginal pain score

  "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"

• Effective vaginal length

  "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"

• Microbiota detection

  "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"

Study Arms (2)

Biafine Group

EXPERIMENTAL

Starting from radiotherapy, in addition to routine care, triethanolamine cream should be applied vaginally twice a day, 4ml each time, until the afterloading is completed.

Drug: Trolamine (Biafine)

Control group

NO INTERVENTION

Routine care

Interventions

Trolamine (Biafine) DRUG

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

Also known as: Observation Group

Biafine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old;
• Those diagnosed with cervical cancer by histological pathology and receiving radiotherapy with a total radiation dose of ≥70Gy;
• ECOG score: 0-2 levels;
• Normal mental state and clear consciousness;
• Be able to cooperate with the visitor;
• Sign the informed consent form.

You may not qualify if:

• Those with severe immune deficiency (such as those who have recently received bone marrow transplantation, with long-term high-dose glucocorticoids \> 20 mg/ day for more than 2 weeks);
• Congenital vaginal malformations;
• Patients who are pregnant, breastfeeding, or have plans and the possibility of becoming pregnant;
• Other conditions that the researcher deems unsuitable for enrollment (such as: previous allergy history to triethanolamine cream, etc.).

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Vaginitis

Interventions

triethanolamine; Biafine

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: March 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 25, 2026

Record last verified: 2025-12