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

Last updated: September 1, 2024
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Urea cream

Liangxue ointment(Traditional Chinese Ointment)

Clinical Study ID

NCT06583369
2022YJZ82
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 communicatenormally;

  • 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 7days before the first dose of the trial drug; men of reproductive potential or womenwith the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, oral contraceptives, Intrauterine device, libidocontrol or barrier method combined with spermicide) and continue contraception for 6months after the end of treatment;

  • Voluntarily participate in this clinical trial, understand the research proceduresand be able to sign the written informed consent form.

Exclusion

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-TKIdrugs or those who have a history of skin diseases;

  • Use of medications within 2 weeks that may affect study results (topicalantibiotics, topical steroids, and other topical treatments);

  • With serious accompanying diseases, such as severe hypertension, diabetes, thyroiddisease, 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 toparticipate in this study.

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Urea cream
Phase:
Study Start date:
March 25, 2024
Estimated Completion Date:
March 25, 2025

Study Description

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.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

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