Zinc Supplement in Regorafenib Treated mCRC Patient (ZnCORRECT)

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer Metastatic

Treatments: Drug: Regorafenib; Dietary Supplement: Zinc gluconate supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03898102

1901090003

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

Regorafenib treatment with Zn supplement

Experimental group

Description:

Patients enrolled in this arm received regorafenib with zinc supplementation to examine if zinc supplementation can decrease the incidence of grade 2 or higher HFSR.

Treatment:

Drug: Regorafenib

Dietary Supplement: Zinc gluconate supplement

Regorafenib treatment only

Active Comparator group

Description:

Patients enrolled in this arm received regorafenib without zinc supplementation, which is the standard treatment of patients of metastatic colorectal cancer who failed previous standard therapy.

Treatment:

Drug: Regorafenib