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this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional chinese medicine TDX105 | Experimental |
|
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional chinese medicine TDX105 | Drug | Experimental group Traditional chinese medicine TDX105 |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of grade 3 hand-foot skin reaction | Evaluation criteria for common adverse events (CTCAE) 5.0 | Once a week from the beginning to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 1-2 hand and foot skin reaction rate | Evaluation criteria for common adverse events (CTCAE) 5.0 | Once a week from the beginning to 2 months |
| Withdrawal rate of regorafenib within 2 cycles |
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Inclusion Criteria:
6. Understand and agree to accept the treatment, and sign the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiping Tian, PhD | Contact | 13651395732 | aipingtian@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer hospital Chinese academy of Medical sciences | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41282614 | Derived | Yu S, Hu X, Tan Y, Wang C, Shao Z, Xiao Y, Liu H, Lv J, Li S, Jiang X, Zeng L, Tian A. Prophylactic effect of the traditional Chinese medicine formula danxiong granules (TDX105) on hand-foot skin reaction associated with the antitumor targeted drug regorafenib: a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2025 Nov 6;16:1641477. doi: 10.3389/fphar.2025.1641477. eCollection 2025. |
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Do not participate in data sharing
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| Placebo | Drug | he control group received placebo granules mixed with dextrin and food coloring |
|
Weekly telephone follow-up
| Once a week from the beginning to 2 months |
| progression-free survival | Response Evaluation Criteria In Solid Tumors 1.1 | 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 | Response Evaluation Criteria In Solid Tumors 1.1 | Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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