The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEG… (NCT06583369) | Clinical Trial Compass
UnknownNot Applicable
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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