Using iron infusions to treat anemia in cancer patients before surgery
Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
PHASE2 · Fox Chase Cancer Center · NCT05800600
This study tests if giving iron infusions to cancer patients before surgery can help improve their blood levels and reduce the need for blood transfusions during chemotherapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fox Chase Cancer Center (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05800600 on ClinicalTrials.gov |
What this trial studies
This open-label, single institution study evaluates the effectiveness of intravenous iron sucrose monotherapy in patients with thoracic, breast, genitourinary, and gastrointestinal cancers who are undergoing neoadjuvant chemotherapy. The study aims to reduce the frequency of blood transfusions and improve hemoglobin levels prior to surgical resection. Patients receiving radiation and immunotherapy as part of their treatment are also included in the study. The goal is to enhance patient outcomes by addressing anemia during chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with anemia (hemoglobin <10.5 g/dL) undergoing neoadjuvant chemotherapy for specific malignancies.
Not a fit: Patients who are diagnosed with anemia at the start of chemotherapy or have hemoglobin levels above 11.0 g/dL may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hemoglobin levels and reduce the need for blood transfusions in patients undergoing chemotherapy.
How similar studies have performed: Other studies have shown promising results with iron infusions in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Iberia Sosa, MD — Fox Chase Cancer Center
- Study coordinator: Ryan Romasko
- Email: ryan.romasko@fccc.edu
- Phone: 2678388380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anemia