Clinical trial NCT06583369: The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
Official title: The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand-Foot Syndrome
Keywords: axitinib
Hand-Foot Syndrome
renal cell carcinoma
Melanoma
VEGFR-TKI
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 2-week treatment effectiveness
timeFrame: Participants will be followed for an expected average of 4 weeks
Secondary outcomes:
measure: Quality of life improvement value
timeFrame: The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment.
measure: Pain relief rate
timeFrame: Participants will be followed for an expected average of 4 weeks
measure: Drug discontinuation and dose reduction rate
timeFrame: Participants will be followed for an expected average of 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References: