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Iron Replacement for Anemia During Chemotherapy

This study is looking at whether giving intravenous (IV) iron, specifically Venofer, can help reduce anemia (low red blood cell count) in patients undergoing chemotherapy for breast, lung (thoracic), stomach/bowel (gastrointestinal), or urinary/reproductive (genitourinary) cancers. You might be able to join if you are over 18, receiving chemotherapy (which can include radiation or immunotherapy) before surgery, and have anemia (hemoglobin less than 10.5 g/dL). The main goal is to see how much your hemoglobin levels improve after receiving Venofer, with measurements taken at 6 weeks. The current status of this study is unclear.

Study design
This is an open-label study, meaning both you and your doctors will know you are receiving Venofer. It is being conducted at a single institution and plans to enroll 34 participants.
What's involved
You would receive five doses of 200 mg of Venofer, given intravenously over 15 minutes to 1 hour each time.
Compensation
Not stated in the trial record.
Follow-up
Your hemoglobin levels will be measured at 6 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05800600

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Fox Chase Cancer Center
~34 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Venofer

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change from baseline to highest Hgb value
Measured over 6 weeks

Conditions

Anemia

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Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Iberia Sosa, MD · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center

Who to contact

Ryan Romasko
[email protected]
2678388380
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Mean change from baseline to highest Hgb value6 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.