RecruitingPhase 2NCT05800600

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Sponsor

Fox Chase Cancer Center

Enrollment

34 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Anemia

Summary

This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Male or female patients > 18 years
Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies.
Anemia defined as Hgb <10.5 g/dL during chemotherapy.
Iron storage levels of ferritin <500 ng/mL and iron saturation <35%
Ability to understand and willingness to sign a written informed consent and HIPAA consent document

Exclusion Criteria7

Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb < 11.0 g/dL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new/exacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Prior parenteral iron infusion in the past 4 weeks
The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD
Concurrent systemic infection at the time of enrollment.
Known hypersensitivity to Iron sucrose
Pregnant or breast feeding. Refer to section 4.4 for further detail.
Anemia from another established etiology (i.e MDS, Myeloma)

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Interventions

DRUGVenofer

Intravenous iron will be administered as five doses of 200 mg of iron sucrose (Venofer, American Regent, Shirley, NJ) in 100 ml normal saline over a duration of 15 minutes to 1 hour