Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer Stage IV; Hand and Foot Skin Reaction

Treatments: Drug: Placebo; Drug: Traditional chinese medicine TDX105

Study type: Interventional

Funder types: Other

Identifiers

NCT05289726

APL21100510010105003002

Details and patient eligibility

About

this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities

Full 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 Ointment on Regorafenib induced Dermatologic Toxicities

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinically confirmed colorectal cancer patients;

2. It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;

3. Performance Status score ≤3;

4. Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms

5. Understand and agree to accept the treatment, and sign the informed consent.

Exclusion criteria

1. 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;
2. Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;
3. Patients in the study who cannot cooperate with the continuation of this treatment;
4. Sudden changes in the patient's condition affected and interfered with the researcher

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups, including a placebo group

Traditional chinese medicine TDX105

Experimental group

Description:

* Experimental group Traditional chinese medicine TDX105 (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib) * Basic care was the same in both groups, including routine care such as topical use of urea ointment

Treatment:

Drug: Traditional chinese medicine TDX105

placebo

Placebo Comparator group

Description:

The control group received placebo granules mixed with dextrin and food coloring (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib) - Basic care was the same in both groups, including routine care such as topical use of urea ointment

Treatment:

Drug: Placebo