Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Fox Chase Cancer Center
• Treatments: Ferric Oxide, Saccharated

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)