Status:
UNKNOWN
Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Hand and Foot Skin Reaction
Colorectal Cancer Stage IV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities
Detailed Description
this is an double blinded controlled preventive study to evaluate the preventive effect of this is an preventive traditional chinese medicine TDX105 plus Urea Ointment compared with placebo plus Urea ...
Eligibility Criteria
Inclusion
- Clinically confirmed colorectal cancer patients;
- It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;
- Performance Status score ≤3;
- Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms
- 6\. Understand and agree to accept the treatment, and sign the informed consent.
Exclusion
- Patients with skin reactions affected by simultaneous use of other targeted drugs (sorafenib, sunitinib, fruquintinib, etc.), chemotherapy drugs (capecitabine, doxorubicin, etc.) or hand-foot radiotherapy;
- Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;
- Patients in the study who cannot cooperate with the continuation of this treatment;
- Sudden changes in the patient's condition affected and interfered with the researcher
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 18 2023
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05289726
Start Date
April 18 2022
End Date
April 18 2023
Last Update
March 21 2022
Active Locations (1)
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1
Cancer hospital Chinese academy of Medical sciences
Beijing, Beijing Municipality, China, 100021