Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Anemia Clinical Trial

— Iron-RANC  

Official title:

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800600
• Other study ID #: 22-1053
• Secondary ID: HM-213
• Status: Recruiting
• Phase: Phase 2
• Start date: March 15, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: August 2023
• Source: Fox Chase Cancer Center
• Contact: Ryan Romasko
• Phone: 2678388380
• Email: ryan.romasko[@]fccc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia

Intervention

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

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline to highest Hgb value	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.	6 weeks
Secondary	Number of transfusions during neo-adjuvant period	To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia and minimizing red blood cell transfusions in patients undergoing neoadjuvant chemotherapy.	24 weeks