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

NCT ID: NCT05289726

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2023-04-18

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 Ointment on Regorafenib induced Dermatologic Toxicities

Conditions

Hand and Foot Skin Reaction; Colorectal Cancer Stage IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Traditional chinese medicine TDX105

• 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

Group Type: EXPERIMENTAL

Traditional chinese medicine TDX105

Intervention Type: DRUG

Experimental group Traditional chinese medicine TDX105

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

he control group received placebo granules mixed with dextrin and food coloring

Interventions

Traditional chinese medicine TDX105

Experimental group Traditional chinese medicine TDX105

Intervention Type: DRUG

Placebo

he control group received placebo granules mixed with dextrin and food coloring

Intervention Type: DRUG

Eligibility Criteria

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

6. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer hospital Chinese academy of Medical sciences

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Aiping Tian, PhD

Role: CONTACT

aipingtian@126.com

13651395732

Facility Contacts

Libo Yao

Role: primary

hejie@cicams.ac.cn

010-87788446

Other Identifiers

APL21100510010105003002

Identifier Type: -

Identifier Source: org_study_id