Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
ConditionAnemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Venofer
DrugIntravenous 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
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Venofer treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 weeksSecondary outcomes
1
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.
Time frame
24 weeksSponsors and contacts
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Source ClinicalTrials.gov