NCT05289726

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

Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Traditional chinese medicine TDX105	Experimental group Traditional chinese medicine TDX105
DRUG	Placebo	he control group received placebo granules mixed with dextrin and food coloring

Timeline

• Start date: 2022-04-18
• Primary completion: 2022-07-18
• Completion: 2023-04-18
• First posted: 2022-03-21
• Last updated: 2022-03-21

Locations

1 site across 1 country: China