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

NCT05289726 | Unknown Phase 2

• 1 other identifier: APL21100510010105003002
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities

Conditions

Hand and Foot Skin Reaction; Colorectal Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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.

Study Arms (2)

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

Drug: Traditional chinese medicine TDX105

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

Drug: Placebo

Interventions

Traditional chinese medicine TDX105 DRUG

Experimental group Traditional chinese medicine TDX105

Traditional chinese medicine TDX105

Placebo DRUG

he control group received placebo granules mixed with dextrin and food coloring

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer hospital Chinese academy of Medical sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• 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.

  PMID: 41282614 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Aiping Tian, PhD

CONTACT

13651395732; aipingtian@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: March 21, 2022
• Study Start: April 18, 2022
• Primary Completion: July 18, 2022
• Study Completion: April 18, 2023
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)