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
Qualifiers
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
Treatments tested in this trial
- Venofer
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov