Multicenter Randomized Study on the Efficacy of Intravenous Iron Injection in Cancer Patients with Anemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0004311

Enrollment

341

Registered

2019-10-14

Start date

2019-12-23

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 227 cases in the Ferinject group,For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle. Patients using t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? The subject should be diagnosed with solid cancer or lymphoma. ? Adults over 19 ?The test subjects must have a history of or have undergone chemotherapy (named chemotherapy, chemotherapy + radiotherapy, target agent, etc.) within 2 months prior to study participation. ? Hemoglobin level of test subject should be in the range of 8.0-10.5g / dL, or he / she has experienced hemoglobin reduction of 2g / dL or more during chemotherapy. ? Subjects should have the ability to prepare / submit informed consent before participating in the study.

Exclusion criteria

Exclusion criteria: ? The patients have a history of iron (oral or intravenous), hematopoietic stimulating agents (ESA), and dialysis within 4 weeks of study enrollment. ? The patients have a history of uncontrolled infection within 4 weeks of study enrollment. ? At the time of study enrollment, subjects have bleeding (ongoing bleeding). ? Deteriorated organ function ? Patients correspond to ECOG performance 3-4 in whole body performance evaluation. ? There is evidence that the patient's disease is a bone marrow invasion. ? There is a hypersensitivity reaction to ferinject or the components of ferinject. ? There is a significant hypersensitivity to other parenteral iron preparations. ? Patients with anemia other than iron deficiency (eg, small red blood anemia) Patients with excessive iron or iron use disorder Patients with advanced bacteremia ? Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Hemoglobin	—

Secondary

Measure	Time frame
Mean Hemoglobin Change;anemia related biochemical variables;Identification of variables predictive for hemoglobin response CBC;adverse events associated with the use of ferric injectables;Evaluate the quality of life with EORTC QLQ-C30.	—

Countries

Korea, Republic of

Contacts

Public ContactYuJeong Choi

Samsung Medical Center

yj123.choi@sbri.co.kr+82-2-3410-3635

Outcome results