Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05800600

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Led by Fox Chase Cancer Center · Updated on 2025-03-11

34

Participants Needed

1

Research Sites

202 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients older than 18 years
  • Undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI), or genitourinary (GU) cancers
  • Anemia defined as hemoglobin less than 10.5 g/dL during chemotherapy
  • Iron storage levels with ferritin less than 500 ng/mL and iron saturation less than 35%
  • Ability to understand and willing to sign informed consent and HIPAA consent documents
Not Eligible

You will not qualify if you...

  • Anemia with hemoglobin less than 11.0 g/dL at cycle 1 day 1 of neoadjuvant chemotherapy
  • Uncontrolled illness such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
  • Prior intravenous iron infusion within 4 weeks
  • Use of erythropoietin stimulating agents within 4 weeks unless for chronic kidney disease
  • Concurrent systemic infection at enrollment
  • Known allergy to iron sucrose
  • Pregnant or breastfeeding
  • Anemia from other known causes such as myelodysplastic syndrome or myeloma

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

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Research Team

R

Ryan Romasko

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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