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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center

Criteria

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%