The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cancer
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2015
CompletedFirst Submitted
Initial submission to the registry
October 7, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 9, 2017
February 1, 2017
2.1 years
October 7, 2015
February 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with Hemoglobin response
visit 4th after Ferinject injection
Study Arms (1)
Subjects
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Irwon-ro ,Kangnam-gu, 06351, South Korea
Related Publications (1)
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.
PMID: 32511251DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 7, 2015
First Posted
November 6, 2015
Study Start
September 12, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
February 9, 2017
Record last verified: 2017-02