← Back to Clinical Trials
Recruiting Phase 2 NCT05800600

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Trial Parameters

Condition Anemia
Sponsor Fox Chase Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 34
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-03-15
Completion 2026-02-01
Interventions
Venofer

Brief 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 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 ag

Related Trials