Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venofer.
- Who it may be relevant to
- Registry conditions: Anemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Detailed 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. The concomitant use of radiation and immunotherapy as part of the neoadjuvant protocol is allowed in this protocol. The study is designed to evaluate the efficacy of iron infusions in reducing blood transfusion frequency and improving hemoglobin levels prior to surgical intervention.
Interventions
- Drug Venofer
Intravenous 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
Primary outcome measures
- Mean change from baseline to highest Hgb value [Time frame: 6 weeks]
Secondary outcome measures (1)
- Number of transfusions during neo-adjuvant period [Time frame: 24 weeks]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fox Chase Cancer Center — Philadelphia
Identifiers
NCT: NCT05800600 · 22-1053 · HM-213