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

Fujian Provincial Cancer Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Radiotherapy Induced Mucositis; Vaginitis

Treatments: Drug: Trolamine (Biafine)

Study type: Interventional

Funder types: Other

Identifiers

NCT07492654

BYFFL-02

Details and patient eligibility

About

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.

Enrollment: 238 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Biafine Group

Experimental group

Description:

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.

Treatment:

Drug: Trolamine (Biafine)

Control group

No Intervention group

Description:

Routine care