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

NCT06583369 | Recruiting DMC

• 1 other identifier: 2022YJZ82
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand-Foot Syndrome

Keywords

axitinib; Hand-Foot Syndrome; renal cell carcinoma; Melanoma; VEGFR-TKI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life improvement value

  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

  Participants will be followed for an expected average of 4 weeks

• Drug discontinuation and dose reduction rate

  Participants will be followed for an expected average of 4 weeks

Study Arms (2)

Liangxue ointment

EXPERIMENTAL

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

Drug: Liangxue ointment（Traditional Chinese Ointment）

urea cream

ACTIVE COMPARATOR

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

Drug: Urea cream

Interventions

Liangxue ointment（Traditional Chinese Ointment） 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.

Liangxue ointment

Urea cream DRUG

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

urea cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Hand-Foot Syndrome; Carcinoma, Renal Cell; Melanoma

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 4, 2024
• Study Start: March 25, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-04

Locations

CN (1)