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COMPLETEDPHASE2

Zinc Supplement in Regorafenib Treated mCRC Patient

Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial

NCT03898102•Chang Gung Memorial Hospital

Summary

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

Detailed Description

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

March 1, 2016

Primary Completion Date

March 1, 2019

Completion Date

March 1, 2019

Last Updated

April 1, 2019

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer Metastatic

Interventions

Regorafenib

DRUG

Zinc gluconate supplement

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Zinc Supplement in Regorafenib Treated mCRC Patient

Inclusion Criteria

Exclusion Criteria

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