VaginitisPhase 4NCT07492654
Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream
A Phase 4 study testing Trolamine (Biafine) in people with Vaginitis and Radiotherapy Induced Mucositis, run by Fujian Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginitis, Radiotherapy Induced Mucositis
- What is being tested?
- Trolamine (Biafine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
About this study
Official title: 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?
Read more
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
- Being tested
- Trolamine (Biafine)
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trolamine (Biafine)Drug
Also called Observation Group
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Trolamine (Biafine) |
| Control group | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: "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
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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492654
- Sponsor's protocol ID
- BYFFL-02
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No