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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06583369
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Peking University Cancer Hospital & Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hand-Foot Syndrome
Additional Details

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.

Arms & Interventions

Arms

Experimental: Liangxue ointment

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.

Interventions

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.

Drug: - Urea cream

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Cancer Hospital, Beijing 1816670, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing 1816670, , 100142

Site Contact

Lu Si, MD

[email protected]

+86(10)88196951

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