Using iron infusions to treat anemia in cancer patients before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single institution study evaluates the effectiveness of intravenous iron sucrose monotherapy in patients with thoracic, breast, genitourinary, and gastrointestinal cancers who are undergoing neoadjuvant chemotherapy. The study aims to reduce the frequency of blood transfusions and improve hemoglobin levels prior to surgical resection. Patients receiving radiation and immunotherapy as part of their treatment are also included in the study. The goal is to enhance patient outcomes by addressing anemia during chemotherapy.

Why it matters

Who can join: the full rules

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)

Where it's running

• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Iberia Sosa, MD — Fox Chase Cancer Center
• Study coordinator: Ryan Romasko
• Email: ryan.romasko@fccc.edu
• Phone: 2678388380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.