Zinc Supplement in Regorafenib Treated mCRC Patient

Colorectal Cancer Metastatic Clinical Trial

— ZnCORRECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898102
• Other study ID #: 1901090003
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib
regorafenib plus zinc gluconate

Dietary Supplement:
• Zinc gluconate supplement
Zinc gluconate supplement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically significant finding in physical examination results, as assessed by HEENT (head, eyes, ears, nose, and throat)	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically significant finding in physical examination results, as assessed by skin	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically significant finding in physical examination results, as assessed by neck (thyroid gland included)	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically significant finding in physical examination results, as assessed by lymph nodes	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically important change in vital sign results from baseline, as assessed by systolic pressure	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically important change in vital sign results from baseline, as assessed by diastolic blood pressure	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically important change in vital sign results from baseline, as assessed by pulse rate	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically important change in vital sign results from baseline, as assessed by respiratory rate	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with clinically important change in vital sign results from baseline, as assessed by body temperature	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by hematology panel	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by biochemistry panel	Percentage	Through study completion, estimated 2 years
Other	Percentage of patients with adverse events (graded by NCI-CTCAE v4.03)	Percentage	Through study completion, estimated 2 years
Primary	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	8 weeks
Secondary	Percentage of zinc deficiency before and after regorafenib treatment at weeks 4	Percentages	4 weeks
Secondary	Percentage of zinc deficiency before and after regorafenib treatment at weeks 8	Percentages	8 weeks
Secondary	Percentage of regorafenib dose reduction	Percentages	Through study completion, estimated 2 years
Secondary	Progression Free Survival (PFS)	months	Through study completion, estimated 2 years
Secondary	Objective tumor response rate (ORR)	rate	Through study completion, estimated 2 years
Secondary	Disease control rate (DCR)	rate	Through study completion, estimated 2 years
Secondary	Overall survival (OS)	months	Through study completion, estimated 2 years
Secondary	Duration of treatment of regorafenib (DoT)	months	through study completion, estimated 2 years