Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03898102
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2019-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zinc Supplement in Regorafenib Treated mCRC Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C559147', 'term': 'regorafenib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-29', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'measure': 'Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'Percentage'}, {'measure': 'Percentage of patients with clinically significant finding in physical examination results, as assessed by skin', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'measure': 'Percentage of patients with clinically significant finding in physical examination results, as assessed by lymph nodes', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'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', 'description': 'Percentage'}, {'measure': 'Percentage of patients with adverse events (graded by NCI-CTCAE v4.03)', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'Percentage'}], 'primaryOutcomes': [{'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', 'description': 'Percentages'}], 'secondaryOutcomes': [{'measure': 'Percentage of zinc deficiency before and after regorafenib treatment at weeks 4', 'timeFrame': '4 weeks', 'description': 'Percentages'}, {'measure': 'Percentage of zinc deficiency before and after regorafenib treatment at weeks 8', 'timeFrame': '8 weeks', 'description': 'Percentages'}, {'measure': 'Percentage of regorafenib dose reduction', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'Percentages'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'months'}, {'measure': 'Objective tumor response rate (ORR)', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'rate'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'rate'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through study completion, estimated 2 years', 'description': 'months'}, {'measure': 'Duration of treatment of regorafenib (DoT)', 'timeFrame': 'through study completion, estimated 2 years', 'description': 'months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer Metastatic']}, 'referencesModule': {'references': [{'pmid': '37968194', 'type': 'DERIVED', 'citation': 'Huang WK, Hsu HC, Yang TS, Lu CW, Pan YR, Wu CE, Chung WH, Hung SI, Yeh CN. Zinc supplementation decreased incidence of grade >/=2 hand-foot skin reaction induced by regorafenib: A phase II randomized clinical trial. Eur J Cancer. 2023 Dec;195:113286. doi: 10.1016/j.ejca.2023.113286. Epub 2023 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* Ability to understand and willingness to sign written Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Patients participating in an investigational program with interventions outside of routine clinical practice\n* Patients with baseline Zinc level above 120 ug/dL\n* Patients with known allergy to Zinc supplementation\n* Pregnancy\n* Patients who are unsuitable for study participation, based on investigator's discretion"}, 'identificationModule': {'nctId': 'NCT03898102', 'acronym': 'ZnCORRECT', 'briefTitle': 'Zinc Supplement in Regorafenib Treated mCRC Patient', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '1901090003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regorafenib treatment with Zn supplement', '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.', 'interventionNames': ['Drug: Regorafenib', 'Dietary Supplement: Zinc gluconate supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regorafenib treatment only', '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.', 'interventionNames': ['Drug: Regorafenib']}], 'interventions': [{'name': 'Regorafenib', 'type': 'DRUG', 'description': 'regorafenib plus zinc gluconate', 'armGroupLabels': ['Regorafenib treatment only', 'Regorafenib treatment with Zn supplement']}, {'name': 'Zinc gluconate supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zinc gluconate supplement', 'armGroupLabels': ['Regorafenib treatment with Zn supplement']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chun-Nan Yeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director, Division of General Surgery', 'investigatorFullName': 'Yeh Chun-Nan', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}