RECRUITINGINTERVENTIONAL
The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- ≥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 willing to sign a consent form form.
Who Should NOT Join This Trial:
- 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;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* ≥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.
Exclusion Criteria:
* 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.
Treatments Being Tested
DRUG
Liangxue ointment（Traditional Chinese Ointment）
The main ingredients of Liangxue Ointment include: Lithospermum sibiricum, Sanguisorba Sanguis, Rehmannia glutinosa, Gardenia, rhubarb, skullcap, borneol, dragon's blood, olibanum and myrrh. Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
DRUG
Urea cream
Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
Locations (1)
Beijing Cancer Hospital
Beijing, China