Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2027-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients

NCT01168505

Breast Cancer

UNKNOWN PHASE2

Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients

NCT03933813

Epithelial Ovarian Cancer Anemia Iron Deficiency Anemia

TERMINATED PHASE1/PHASE2

Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced

NCT00210002

Neoplasms Anemia

TERMINATED PHASE2

Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

NCT00283621

Sarcoma

COMPLETED NA

Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia

NCT00497809

Breast Cancer Neutropenia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Venofer treatment

Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion

Group Type EXPERIMENTAL

Venofer

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No