Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Phase 2

Recruiting

• Conditions: Anemia
• Interventions: Drug: Venofer

• Registration Number: NCT05800600
• Lead Sponsor: Fox Chase Cancer Center

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.

Detailed Description

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. The concomitant use of radiation and immunotherapy as part of the neoadjuvant protocol is allowed in this protocol. The study is designed to evaluate the efficacy of iron infusions in reducing blood transfusion frequency and improving hemoglobin levels prior to surgical intervention.

Study Timeline

• Study Start: 2023-03-15
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-04-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venofer treatment	Venofer	Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion

Primary Outcome Measures

Name	Time	Method
Mean change from baseline to highest Hgb value	6 weeks	To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia by improving the hemoglobin of patients undergoing neoadjuvant chemotherapy.; Mean change from baseline to highest Hgb value observed six weeks after last iron infusion, before day of surgery.

Secondary Outcome Measures

Name	Time	Method
Number of transfusions during neo-adjuvant period	24 weeks	To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia and minimizing red blood cell transfusions in patients undergoing neoadjuvant chemotherapy.

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States