The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by regorafenib

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-jRCTs031180096
• Lead Sponsor: ishizawa Aya

Brief Summary

The primary endpoint, the incidence of Grade 3 hand-foot syndrome , was 7.4%, which was statistically significant assuming a threshold of 30%, and therefore the protocol treatment in the study was judged to be effective. However, the study was limited by the large number of patients who discontinued protocol treatment during the course of the study, and it is unclear whether the incidence of Grade 3 hand-foot syndrome would not increase even if those patients were able to continue to complete the protocol.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-25
• Study Completion: 2021-09-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1)Colorectal cancer patients who are scheduled to be on Regorafenib
2)Patients are scheduled to be administered the drugs at a dose of 120mg
3) PS0-1
4) Written informed consent for this study can be obtained from the patients.

Exclusion Criteria

1) Patients with fissure or erosion in the palmoplantar area
2) Patients with a history of sympathectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified