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

Primary Purpose

Cancer, Anemia

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ferinject®
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with Hemoglobin response

Secondary Outcome Measures

Full Information

First Posted
October 7, 2015
Last Updated
February 7, 2017
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02599012
Brief Title
The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2015 (Actual)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ferinject®
Intervention Description
intravenous Ferinject 1000mg injection
Primary Outcome Measure Information:
Title
Number of participants with Hemoglobin response
Time Frame
visit 4th after Ferinject injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Irwon-ro ,Kangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JiYoung Choi
Phone
82-2-3410-3660
Email
jy210.choi@samsung.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32511251
Citation
Jang JH, Kim Y, Park S, Kim K, Kim SJ, Kim WS, Jung CW, Lee J, Lee SH. Efficacy of intravenous iron treatment for chemotherapy-induced anemia: A prospective Phase II pilot clinical trial in South Korea. PLoS Med. 2020 Jun 8;17(6):e1003091. doi: 10.1371/journal.pmed.1003091. eCollection 2020 Jun.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Iron+deficient+erythropoiesis+might+play+key+role+in+development+of+anemia+in+cancer+patients
Description
Iron deficient erythropoiesis might play key role in development of anemia in cancer patients.

Learn more about this trial

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

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