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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-12

Study Completion Date

2017-12-31

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Cancer Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects

Group Type EXPERIMENTAL

Ferinject®

Intervention Type DRUG

intravenous Ferinject 1000mg injection

Interventions

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Ferinject®

intravenous Ferinject 1000mg injection

Intervention Type DRUG

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No