Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream: An Open-label, Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 238
- 主要终点
- Incidence and severity of radiation vaginitis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.).
结局指标
主要结局
Incidence and severity of radiation vaginitis
时间窗: "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".
次要结局
- Vaginal mucosal healing rate("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)("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("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("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("First radiotherapy", "35 ± 7 days after the first radiotherapy", "50 ± 3 days after the first radiotherapy", "140 ± 7 days after the first radiotherapy")