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

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.

Study Overview

• Status: Recruiting
• Conditions: Hand-Foot Syndrome
• Intervention / Treatment: Drug: Liangxue ointment（Traditional Chinese Ointment）; Drug: Urea cream

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Lu Si, MD; Phone Number: +86(10)88196951; Email: silu.net@hotmail.com
    • Sub-Investigator: Lu Si, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liangxue ointment; Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.	Drug: 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.
Active Comparator: urea cream; Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.	Drug: Urea cream; Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-week treatment effectiveness	According to the patient's NCI CTCAE grade improvement, it is divided into: 1) The clinical symptoms completely disappear, which is a complete remission; 2) The symptom grade decreases by 1 level or more (not including falling to level 0), which is a partial remission; 3) There is no change in symptoms. , is invalid. Calculate the treatment effectiveness at different time points respectively, and take the 2-week treatment effectiveness as the main research endpoint.	Participants will be followed for an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life improvement value	Quality of life improvement value: According to the HFS-14 scale, patients' quality of life scores were scored before and after treatment. Quality of life improvement value = quality of life score before treatment - quality of life score after treatment. The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment.	The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment.
Pain relief rate	Pain relief rate: The NRS numerical scoring method is used to evaluate the pain before and after treatment: 1) The disappearance of pain after treatment is complete relief; 2) The pain score after treatment / the pain score before treatment ≤50% is effective; 3) There is no change in pain, which is invalid. Pain relief rate = (number of complete relief cases + number of effective cases)/total number of cases × 100%.	Participants will be followed for an expected average of 4 weeks
Drug discontinuation and dose reduction rate	Drug discontinuation and dose reduction: the rate of drug discontinuation or dose reduction in the two groups due to severe hand-foot syndrome caused by VEGFR-TKI drugs.	Participants will be followed for an expected average of 4 weeks

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): March 25, 2025
• Study Completion (Estimated): March 25, 2025

Study Registration Dates

• First Submitted: September 1, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Melanoma; axitinib; renal cell carcinoma; Hand-Foot Syndrome; VEGFR-TKI
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Skin Diseases; Disease; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Syndrome; Hand-Foot Syndrome
• Other Study ID Numbers: 2022YJZ82

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No