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

JRCT ID: jRCTs031180096

Registered date:25/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 01/02/2019
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Effectiveness of prevention of hand-foot syndrome associated with Regorafenib by using aluminum chloride and wound dressing

Outcome(s)

• Primary Outcome: Incidence of Grade 3 HFS
• Secondary Outcome: Incidence of hand-foot syndrome including all grades, duration until the initial presentation of hand-foot syndrome, duration until the presentaion of hand-foot syndrome with more than grade 2, duration between the presentation of hand-foot syndrome with more than grade 2 and the improvement in the symptoms with the grade decreased to grade 1 or 0, the incidence of cases with reducing the dose of Regorafenib due to hand-foot syndrome, incidence of drug withdrawal due to hand-foot syndrome, the incidence of cases with treatment withdrawal due to hand-foot syndrome, incidence of discontinue medication of regorafenib due to hand-foot syndrome, incidence of side effects by alminum chloride

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 100age old
• Gender: Both

Include 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.

Exclude criteria

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

Related Information

• Primary Sponsor: Nishizawa Aya
• Source(s) of Monetary Support: Sumitomo Mitsui Trust Bank,Grants-in-Aid for Sientific Research