The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- 2-week treatment effectiveness
研究概览
简要总结
This study was a prospective, single-center randomized controlled trial. The subject of this study is to evaluate the effectiveness and safety of traditional Chinese medicine Liangxue Ointment in the treatment of hand-foot syndrome caused by VEGFR-TKI drugs.
详细描述
This study was a prospective, single-center randomized controlled trial. Patients with hand-foot syndrome caused by VEGFR-TKI drugs were randomly divided into the experimental group and the control group at a ratio of 1:1 according to the numerical randomization method. All patients are required to avoid inappropriate local friction of hands and feet; avoid heavy physical labor and sun exposure; eat a light diet, avoid spicy and irritating foods, and keep warm. The control group received urea cream application, and the experimental group received Liangxue ointment application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old, both men and women are welcome;
- •Patients with pathologically confirmed malignant tumors;
- •Receive treatment with VEGFR-TKI drugs;
- •Hand-foot syndrome associated with VEGFR-TKI drugs is judged by the researcher;
- •No skin lesions on hands and feet before receiving VEGFR-TKI drug treatment;
- •No allergies to the traditional Chinese medicine components of the trial drug;
- •Be conscious, have language expression or reading skills, and can communicate normally;
- •Estimated survival time ≥3 months;
- •ECOG score ≤ 2;
- •Ability to comply with the trial protocol, as judged by the investigator;
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of the trial drug; men of reproductive potential or women with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, oral contraceptives, Intrauterine device, libido control or barrier method combined with spermicide) and continue contraception for 6 months after the end of treatment;
- •Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the written informed consent form.
排除标准
- •Those with skin ulcers on hands and feet;
- •Known allergy to ingredients of Liangxue Ointment;
- •Have used other targeted drugs and chemotherapy drugs that cause HFS within 4 weeks;
- •Those who have skin lesions on their hands and feet before treatment with VEGFR-TKI drugs or those who have a history of skin diseases;
- •Use of medications within 2 weeks that may affect study results (topical antibiotics, topical steroids, and other topical treatments);
- •With serious accompanying diseases, such as severe hypertension, diabetes, thyroid disease, heart disease, and mental illness;
- •Poor compliance and refusal to cooperate with follow-up visits;
- •Other reasons lead the researcher to believe that they are not suitable to participate in this study.
研究组 & 干预措施
Liangxue ointment
Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
干预措施: Liangxue ointment（Traditional Chinese Ointment） (Drug)
urea cream
Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
干预措施: Urea cream (Drug)
结局指标
主要结局
2-week treatment effectiveness
时间窗: Participants will be followed for an expected average of 4 weeks
According to the patient's NCI CTCAE grade improvement, it is divided into: 1) The clinical symptoms completely disappear, which is a complete remission; 2) The symptom grade decreases by 1 level or more (not including falling to level 0), which is a partial remission; 3) There is no change in symptoms. , is invalid. Calculate the treatment effectiveness at different time points respectively, and take the 2-week treatment effectiveness as the main research endpoint.
次要结局
- Quality of life improvement value(The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment.)
- Pain relief rate(Participants will be followed for an expected average of 4 weeks)
- Drug discontinuation and dose reduction rate(Participants will be followed for an expected average of 4 weeks)
研究者
Lu Si
professor
Peking University Cancer Hospital & Institute