Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

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.

Conditions

Anemia

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Study Overview

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Study Details

Study overview

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.

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Condition
Anemia
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, 19111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fox Chase Cancer Center,

Iberia Sosa, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

2026-02-01