NCT03898102

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2016

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 27, 2019

Last Update Submit

March 29, 2019

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (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

    Percentages

    8 weeks

Secondary Outcomes (8)

  • Percentage of zinc deficiency before and after regorafenib treatment at weeks 4

    4 weeks

  • Percentage of zinc deficiency before and after regorafenib treatment at weeks 8

    8 weeks

  • Percentage of regorafenib dose reduction

    Through study completion, estimated 2 years

  • Progression Free Survival (PFS)

    Through study completion, estimated 2 years

  • Objective tumor response rate (ORR)

    Through study completion, estimated 2 years

  • +3 more secondary outcomes

Other Outcomes (14)

  • Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance

    Through study completion, estimated 2 years

  • Percentage of patients with clinically significant finding in physical examination results, as assessed by HEENT (head, eyes, ears, nose, and throat)

    Through study completion, estimated 2 years

  • Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth

    Through study completion, estimated 2 years

  • +11 more other outcomes

Study Arms (2)

Regorafenib treatment with Zn supplement

EXPERIMENTAL

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: RegorafenibDietary Supplement: Zinc gluconate supplement

Regorafenib treatment only

ACTIVE COMPARATOR

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

Interventions

RegorafenibDRUG

regorafenib plus zinc gluconate

Regorafenib treatment onlyRegorafenib treatment with Zn supplement
Zinc gluconate supplementDIETARY_SUPPLEMENT

Zinc gluconate supplement

Regorafenib treatment with Zn supplement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37968194DERIVED

MeSH Terms

Interventions

regorafenib

Study Officials

  • Chun-Nan Yeh, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Division of General Surgery

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 1, 2019

Study Start

March 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

April 1, 2019

Record last verified: 2019-03