Trials / Completed
CompletedNCT03898102
Zinc Supplement in Regorafenib Treated mCRC Patient
Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Chang Gung Memorial Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Regorafenib | regorafenib plus zinc gluconate |
| DIETARY_SUPPLEMENT | Zinc gluconate supplement | Zinc gluconate supplement |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2019-03-01
- Completion
- 2019-03-01
- First posted
- 2019-04-01
- Last updated
- 2019-04-01
Source: ClinicalTrials.gov record NCT03898102. Inclusion in this directory is not an endorsement.