RECRUITING

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Quick Facts

Study Start:2023-03-15

Study Completion:2026-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05800600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Ryan Romasko

CONTACT

2678388380

ryan.romasko@fccc.edu

Principal Investigator

Iberia Sosa, MD

PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

Iberia Sosa, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15

Study Completion Date2026-02-01

Study Record Updates

Study Start Date2023-03-15

Study Completion Date2026-02-01

Terms related to this study

Additional Relevant MeSH Terms

Anemia