Clinical trial · Interventional
Zinc Supplement in Regorafenib Treated mCRC Patient
Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial
NCT03898102CI-TRIAL-00037875ZnCORRECTcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib | Drug | Regorafenib | ALIAS |
| Zinc gluconate supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHuang 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 37968194