A Phase 4 interventional study of Trolamine (Biafine) in Vaginitis and Radiotherapy Induced Mucositis, sponsored by Fujian Cancer Hospital. Not yet recruiting. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Fujian Cancer Hospital · Phase 4, Interventional, and Prevention
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.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's planned enrollment of 238 is above the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →Fujian Cancer Hospital is the lead sponsor of 163 studies on the registry; 93 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Routine care
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
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".
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 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.
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)
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.
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
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.
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
The maximum depth that can be tolerated from the entrance to the dome (or stump) with a graduated expander/ruler.
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
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.
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"
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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