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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

Search all trials

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
Are there results?: Not yet: the study is under way

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

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
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 groups in NCT07492654
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.

1 Mar 202631 Dec 2030

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.
More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
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)

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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

All Vaginitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream: An Open-label, Multicenter, Randomized Controlled Study
ClinicalTrials.gov ID: NCT07492654
Acronym / sponsor ID: BYFFL-02
Conditions: Vaginitis, Radiotherapy Induced Mucositis
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 238 participants (estimated)
Lead sponsor: Fujian Cancer HospitalOther government
Study start: 1 Mar 2026 (estimated)
Primary completion: 31 Dec 2030 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 25 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

Participants will:

Four examinations were conducted respectively from before radiotherapy to 90 days after its end.

Record their symptoms and conduct injury scoring.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Biafine Group	Experimental	Drug: Trolamine (Biafine)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.
Control group	No intervention	–Routine care

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (4 listed)

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.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trolamine (Biafine)Also: Observation GroupAfter 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	Drug	Biafine Group

Primary outcome

Incidence and severity of radiation vaginitis
Time frame: "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"
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".

5 secondary outcomes

Vaginal mucosal healing rate
Time frame: "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)
Time frame: "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
Time frame: "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
Time frame: "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
Time frame: "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.

Related trials for Vaginitis

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trolamine (Biafine) in people with Vaginitis and Radiotherapy Induced Mucositis, run by Fujian Cancer Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of radiation vaginitis (time frame: "First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07492654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.