Using Liangxue Ointment to treat hand-foot syndrome from cancer drugs

The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs

This study is testing if Liangxue Ointment can help people with hand-foot syndrome caused by cancer drugs feel better compared to using regular urea cream.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06583369 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of Liangxue Ointment, a traditional Chinese medicine, in treating hand-foot syndrome caused by VEGFR-TKI drugs. It is a prospective, single-center randomized controlled trial where patients are divided into two groups: one receiving Liangxue Ointment and the other receiving urea cream. Participants are instructed to avoid certain activities and maintain a light diet during the trial. The aim is to determine if Liangxue Ointment can provide better relief from symptoms compared to the standard treatment.

Who should consider this trial

Good fit: Ideal candidates include adults with confirmed malignant tumors who are experiencing hand-foot syndrome from VEGFR-TKI drugs.

Not a fit: Patients without hand-foot syndrome or those with severe skin lesions prior to treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients suffering from hand-foot syndrome due to cancer therapies.

How similar studies have performed: While traditional Chinese medicine approaches have been explored, the specific use of Liangxue Ointment for this condition is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (Recruiting)

Conditions Hand-Foot Syndrome; axitinib; renal cell carcinoma; Melanoma; VEGFR-TKI