Clinical trial NCT03898102: Zinc Supplement in Regorafenib Treated mCRC Patient
Official title: Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer Metastatic
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: 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
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of zinc deficiency before and after regorafenib treatment at weeks 4
timeFrame: 4 weeks
measure: Percentage of zinc deficiency before and after regorafenib treatment at weeks 8
timeFrame: 8 weeks
measure: Percentage of regorafenib dose reduction
timeFrame: Through study completion, estimated 2 years
measure: Progression Free Survival (PFS)
timeFrame: Through study completion, estimated 2 years
measure: Objective tumor response rate (ORR)
timeFrame: Through study completion, estimated 2 years
measure: Disease control rate (DCR)
timeFrame: Through study completion, estimated 2 years
measure: Overall survival (OS)
timeFrame: Through study completion, estimated 2 years
measure: Duration of treatment of regorafenib (DoT)
timeFrame: through study completion, estimated 2 years
Other outcomes:
measure: Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically significant finding in physical examination results, as assessed by HEENT (head, eyes, ears, nose, and throat)
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically significant finding in physical examination results, as assessed by skin
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically significant finding in physical examination results, as assessed by neck (thyroid gland included)
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically significant finding in physical examination results, as assessed by lymph nodes
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically important change in vital sign results from baseline, as assessed by systolic pressure
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically important change in vital sign results from baseline, as assessed by diastolic blood pressure
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically important change in vital sign results from baseline, as assessed by pulse rate
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically important change in vital sign results from baseline, as assessed by respiratory rate
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with clinically important change in vital sign results from baseline, as assessed by body temperature
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by hematology panel
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by biochemistry panel
timeFrame: Through study completion, estimated 2 years
measure: Percentage of patients with adverse events (graded by NCI-CTCAE v4.03)
timeFrame: Through study completion, estimated 2 years
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chun-Nan Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References: