NCT05800600

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Venofer	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

Timeline

• Start date: 2023-03-15
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2023-04-05
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study