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

NCT ID: NCT06583369

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2025-03-25

Brief 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.

Detailed 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.

Conditions

Hand-Foot Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liangxue ointment

Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.

Group Type: EXPERIMENTAL

Liangxue ointment（Traditional Chinese Ointment）

Intervention Type: DRUG

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.

urea cream

Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.

Group Type: ACTIVE_COMPARATOR

Urea cream

Intervention Type: DRUG

Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.

Interventions

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.

Intervention Type: DRUG

Urea cream

Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Lu Si

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Lu Si, MD

Role: primary

silu.net@hotmail.com

+86(10)88196951

Other Identifiers

2022YJZ82

Identifier Type: -

Identifier Source: org_study_id