NCT05800600 Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
| NCT ID | NCT05800600 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fox Chase Cancer Center |
| Condition | Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 34 participants in total. It began in 2023-03-15 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Iberia Sosa, MD
PRINCIPAL INVESTIGATOR
Fox Chase Cancer Center
Frequently Asked Questions
Who can join the NCT05800600 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05800600 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05800600 currently recruiting?
Yes, NCT05800600 is actively recruiting participants. Contact the research team at ryan.romasko@fccc.edu for enrollment information.
Where is the NCT05800600 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05800600 clinical trial?
NCT05800600 is sponsored by Fox Chase Cancer Center. The principal investigator is Iberia Sosa, MD at Fox Chase Cancer Center. The trial plans to enroll 34 participants.