The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients

Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02599012
• Other study ID #: 2015-01-011-001
• Status: Recruiting
• Phase: Phase 2
• First received: October 7, 2015
• Last updated: February 7, 2017
• Start date: September 12, 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.

• Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.

• Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.

• In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who diagnosed with solid cancer or lymphoma

• Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment

• anticancer therapy: "chemotherapy", and/or "chemotherapy + radiotherapy", and/or "target agent"

• Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment

Exclusion Criteria:

• Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment

• Subjects with uncontrolled infection

• Subjects with ongoing bleeding

• Deteriorated organ function

• poor performance state (ECOG 3-4)

• Subjects whose disease involves bone marrow

• Ferritin > 800 ng/ml and Transferrin saturation(TSAT) = 50%

Related Conditions & MeSH terms

• Anemia
• Cancer

Intervention

Drug:
• Ferinject®
intravenous Ferinject 1000mg injection

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Irwon-ro ,Kangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Hemoglobin response		visit 4th after Ferinject injection

External Links

•   Iron deficient erythropoiesis might play key role in development of anemia in cancer patients.