Back to resultsStudy on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105
Primary Purpose
Hand and Foot Skin Reaction, Colorectal Cancer Stage IV
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Traditional chinese medicine TDX105
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hand and Foot Skin Reaction
Eligibility Criteria
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
6. 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
Sites / Locations
- Cancer hospital Chinese academy of Medical sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Traditional chinese medicine TDX105
placebo
Arm 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
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
Outcomes
Primary Outcome Measures
incidence of grade 3 hand-foot skin reaction
Evaluation criteria for common adverse events (CTCAE) 5.0
Secondary Outcome Measures
Grade 1-2 hand and foot skin reaction rate
Evaluation criteria for common adverse events (CTCAE) 5.0
Withdrawal rate of regorafenib within 2 cycles
Weekly telephone follow-up
progression-free survival
Response Evaluation Criteria In Solid Tumors 1.1
tumor control rate
Response Evaluation Criteria In Solid Tumors 1.1
Full Information
NCT ID
NCT05289726
First Posted
December 10, 2021
Last Updated
March 11, 2022
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05289726
Brief Title
Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105
Official Title
Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 18, 2022 (Anticipated)
Primary Completion Date
July 18, 2022 (Anticipated)
Study Completion Date
April 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand and Foot Skin Reaction, Colorectal Cancer Stage IV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional chinese medicine TDX105
Arm Type
Experimental
Arm 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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Traditional chinese medicine TDX105
Intervention Description
Experimental group Traditional chinese medicine TDX105
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
he control group received placebo granules mixed with dextrin and food coloring
Primary Outcome Measure Information:
Title
incidence of grade 3 hand-foot skin reaction
Description
Evaluation criteria for common adverse events (CTCAE) 5.0
Time Frame
Once a week from the beginning to 2 months
Secondary Outcome Measure Information:
Title
Grade 1-2 hand and foot skin reaction rate
Description
Evaluation criteria for common adverse events (CTCAE) 5.0
Time Frame
Once a week from the beginning to 2 months
Title
Withdrawal rate of regorafenib within 2 cycles
Description
Weekly telephone follow-up
Time Frame
Once a week from the beginning to 2 months
Title
progression-free survival
Description
Response Evaluation Criteria In Solid Tumors 1.1
Time Frame
Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
Title
tumor control rate
Description
Response Evaluation Criteria In Solid Tumors 1.1
Time Frame
Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
6. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aiping Tian, PhD
Phone
13651395732
Email
aipingtian@126.com
Facility Information:
Facility Name
Cancer hospital Chinese academy of Medical sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Libo Yao
Phone
010-87788446
Email
hejie@cicams.ac.cn
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Do not participate in data sharing
Learn more about this trial
Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105
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