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Zinc Supplement in Regorafenib Treated mCRC Patient (ZnCORRECT)

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ClinicalTrials.gov Identifier: NCT03898102
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Yeh Chun-Nan, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: Regorafenib Dietary Supplement: Zinc gluconate supplement Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Regorafenib treatment with Zn supplement
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.
Drug: Regorafenib
regorafenib plus zinc gluconate

Dietary Supplement: Zinc gluconate supplement
Zinc gluconate supplement

Active Comparator: Regorafenib treatment only
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.
Drug: Regorafenib
regorafenib plus zinc gluconate




Primary Outcome Measures :
  1. 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 [ Time Frame: 8 weeks ]
    Percentages


Secondary Outcome Measures :
  1. Percentage of zinc deficiency before and after regorafenib treatment at weeks 4 [ Time Frame: 4 weeks ]
    Percentages

  2. Percentage of zinc deficiency before and after regorafenib treatment at weeks 8 [ Time Frame: 8 weeks ]
    Percentages

  3. Percentage of regorafenib dose reduction [ Time Frame: Through study completion, estimated 2 years ]
    Percentages

  4. Progression Free Survival (PFS) [ Time Frame: Through study completion, estimated 2 years ]
    months

  5. Objective tumor response rate (ORR) [ Time Frame: Through study completion, estimated 2 years ]
    rate

  6. Disease control rate (DCR) [ Time Frame: Through study completion, estimated 2 years ]
    rate

  7. Overall survival (OS) [ Time Frame: Through study completion, estimated 2 years ]
    months

  8. Duration of treatment of regorafenib (DoT) [ Time Frame: through study completion, estimated 2 years ]
    months


Other Outcome Measures:
  1. Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  2. Percentage of patients with clinically significant finding in physical examination results, as assessed by HEENT (head, eyes, ears, nose, and throat) [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  3. Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  4. Percentage of patients with clinically significant finding in physical examination results, as assessed by skin [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  5. Percentage of patients with clinically significant finding in physical examination results, as assessed by neck (thyroid gland included) [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  6. Percentage of patients with clinically significant finding in physical examination results, as assessed by lymph nodes [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  7. Percentage of patients with clinically important change in vital sign results from baseline, as assessed by systolic pressure [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  8. Percentage of patients with clinically important change in vital sign results from baseline, as assessed by diastolic blood pressure [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  9. Percentage of patients with clinically important change in vital sign results from baseline, as assessed by pulse rate [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  10. Percentage of patients with clinically important change in vital sign results from baseline, as assessed by respiratory rate [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  11. Percentage of patients with clinically important change in vital sign results from baseline, as assessed by body temperature [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  12. Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by hematology panel [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  13. Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by biochemistry panel [ Time Frame: Through study completion, estimated 2 years ]
    Percentage

  14. Percentage of patients with adverse events (graded by NCI-CTCAE v4.03) [ Time Frame: Through study completion, estimated 2 years ]
    Percentage



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898102


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chun-Nan Yeh, MD Chang Gung Memorial Hospital

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Responsible Party: Yeh Chun-Nan, Professor and Director, Division of General Surgery, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03898102     History of Changes
Other Study ID Numbers: 1901090003
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs