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Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy (Iron-RANC)

Primary Purpose

Anemia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Venofer
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Fox Chase Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venofer treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Mean change from baseline to highest Hgb value
To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia by improving the hemoglobin of patients undergoing neoadjuvant chemotherapy. Mean change from baseline to highest Hgb value observed six weeks after last iron infusion, before day of surgery.

Secondary Outcome Measures

Number of transfusions during neo-adjuvant period
To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia and minimizing red blood cell transfusions in patients undergoing neoadjuvant chemotherapy.

Full Information

First Posted
March 24, 2023
Last Updated
August 23, 2023
Sponsor
Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05800600
Brief Title
Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
Acronym
Iron-RANC
Official Title
Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venofer treatment
Arm Type
Experimental
Arm Description
Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
Venofer
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean change from baseline to highest Hgb value
Description
To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia by improving the hemoglobin of patients undergoing neoadjuvant chemotherapy. Mean change from baseline to highest Hgb value observed six weeks after last iron infusion, before day of surgery.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of transfusions during neo-adjuvant period
Description
To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia and minimizing red blood cell transfusions in patients undergoing neoadjuvant chemotherapy.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Romasko
Phone
2678388380
Email
ryan.romasko@fccc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iberia Sosa, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Romasko
Phone
267-838-8380
Email
ryan.romasko@fccc.edu
First Name & Middle Initial & Last Name & Degree
Iberia Sosa, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

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