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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginitis; Radiotherapy Induced Mucositis
• Intervention / Treatment: Drug: Trolamine (Biafine)

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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);
2. Congenital vaginal malformations;
3. Patients who are pregnant, breastfeeding, or have plans and the possibility of becoming pregnant;
4. Other conditions that the researcher deems unsuitable for enrollment (such as: previous allergy history to triethanolamine cream, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Routine care
Experimental: Biafine Group; 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); 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; Other Names: Observation Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal mucosal healing rate	The criteria for "healing" are defined as the simultaneous satisfaction of CTCAE5.0 grade ≤1, patient self-assessed VAS≤1 point (at rest), and no visible erosion or erosion area <5 mm ². In the visit records, all the established corresponding details should be marked with "√", and the content should be blind reviewed by two or more assessors to reduce the subjective judgment error of a single physician. If there is a disagreement in the assessment results, a third party shall arbitrate.	"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)	The full name of EORTC QLQ-CX24 is "European Organization for Research and Treatment of Cancer Cervical Cancer Patient Quality of Life Questionnaire Module".Its high reliability, validity and international comparability make it a "gold standard" tool for assessing the quality of life of cervical cancer patients, optimizing treatment strategies, and conducting global multi-center studies. A refined index system covering symptoms, physical appearance and sexual-reproductive functions has been provided. There are a total of 24 items, including 11 items for symptom experience, 3 items for physical appearance, 4 items for sexual/vaginal functions, 1 item each for lymphedema, peripheral neuropathy, menopause symptoms, sexual concerns, sexual life, and sexual enjoyment. All items use a 4-point Likert scale (1 = no - 4 = very much). The raw scores are first calculated, and then linear transformation formulas are used to convert them into a 0-100 scale.	"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	The Visual Analogue Scale (VAS) is a 10 cm (100 mm) marked straight line used to enable subjects to convert subjective pain intensity into quantifiable continuous values. When evaluating vaginal pain/dyspareunia, VAS is recommended as a single-dimensional, highly sensitive and easily statistically processed tool. It has been widely used in research and clinical follow-up after vaginal surgery or radiotherapy, vulvar pain syndrome, endometria-related pelvic pain, etc.	"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	The maximum depth that can be tolerated from the entrance to the dome (or stump) with a graduated expander/ruler.	"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	The changes of flora in the secretions were observed respectively before external irradiation treatment, at the end of the last brachytherapy, and 90 days after the end of the last brachytherapy.	"First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vaginal Diseases; Vaginitis; Biafine; triethanolamine
• Other Study ID Numbers: BYFFL-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No