NCT05289726UnknownPhase 2
Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country152 target enrollmentStarted: April 18, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- incidence of grade 3 hand-foot skin reaction
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Understand and agree to accept the treatment, and sign the informed consent.
Exclusion Criteria
- •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
Arms & Interventions
Traditional chinese medicine TDX105
Experimental
- 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
Intervention: Traditional chinese medicine TDX105 (Drug)
placebo
Placebo Comparator
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
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
incidence of grade 3 hand-foot skin reaction
Time Frame: Once a week from the beginning to 2 months
Evaluation criteria for common adverse events (CTCAE) 5.0
Secondary Outcomes
- Grade 1-2 hand and foot skin reaction rate(Once a week from the beginning to 2 months)
- Withdrawal rate of regorafenib within 2 cycles(Once a week from the beginning to 2 months)
- 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.)
- 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.)
Investigators
Study Sites (1)
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