The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEG… (NCT06583369) | Clinical Trial Compass
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The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
China220 participantsStarted 2024-03-25
Plain-language summary
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 can participate
Age range18 Years
SexALL
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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 treatmen…
What they're measuring
1
2-week treatment effectiveness
Timeframe: Participants will be followed for an expected average of 4 weeks
Trial details
NCT IDNCT06583369
SponsorPeking University Cancer Hospital & Institute