Colorectal Cancer Stage IV, Hand and Foot Skin Reaction
Conditions
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
Interventions
DRUGTraditional chinese medicine TDX105
Experimental group Traditional chinese medicine TDX105
DRUGPlacebo
he control group received placebo granules mixed with dextrin and food coloring
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of grade 3 hand-foot skin reaction | Once a week from the beginning to 2 months | Evaluation criteria for common adverse events (CTCAE) 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade 1-2 hand and foot skin reaction rate | Once a week from the beginning to 2 months | Evaluation criteria for common adverse events (CTCAE) 5.0 |
| Withdrawal rate of regorafenib within 2 cycles | Once a week from the beginning to 2 months | Weekly telephone follow-up |
| progression-free survival | Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months. | Response Evaluation Criteria In Solid Tumors 1.1 |
| tumor control rate | Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months. | Response Evaluation Criteria In Solid Tumors 1.1 |
Countries
China
Contacts
Primary ContactAiping Tian, PhD
Outcome results
None listed