Zinc Supplement in Regorafenib Treated mCRC Patient

Chang Gung Memorial Hospital65 enrolled

Overview

Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.

This study is aimed to investigate the effect of zinc supplementation on improving regorafenib treatment safety and efficacy in patients with metastatic colorectal cancer (mCRC). The difference in grade 2 or worse hand-foot skin reaction (HFSR) incidence within the first 8 weeks of regorafenib treatment between two arms will be examined as the primary objective.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Colorectal Cancer Metastatic

Interventions

RegorafenibDRUG

regorafenib plus zinc gluconate

Zinc gluconate supplementDIETARY_SUPPLEMENT

Zinc gluconate supplement

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib * Ability to understand and willingness to sign written Informed Consent Form (ICF) Exclusion Criteria: * Patients participating in an investigational program with interventions outside of routine clinical practice * Patients with baseline Zinc level above 120 ug/dL * Patients with known allergy to Zinc supplementation * Pregnancy * Patients who are unsuitable for study participation, based on investigator's discretion

Outcomes

Primary Outcomes

Difference in grade 2 or worse HFSR incidence within the first 8 weeks of regorafenib treatment between mCRC patients who receive regorafenib treatment with or without zinc supplementation

Percentages

Time frame: 8 weeks

Secondary Outcomes

Percentage of zinc deficiency before and after regorafenib treatment at weeks 4

Percentages

Time frame: 4 weeks

Percentage of zinc deficiency before and after regorafenib treatment at weeks 8

Percentages

Time frame: 8 weeks

Percentage of regorafenib dose reduction

Percentages