Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer

A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of Patient Blood Management Program in Patients With Gynecologic Cancer

To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml; Drug: RBC

Detailed Description

To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients undergoing surgery, radiation therapy, and chemotherapy, and to establish a patient blood management program and introduce it as a standard treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 334
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeong-Yeol Park, M.D., Ph.D; Phone Number: +821074748988; Email: catgut1-0@hanmail.net
• Study Contact Backup: Name: Ok Ju Kang, M.D.; Phone Number: 82-10-2320-5499; Email: lalala1301@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged 20-80 years
2. Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer)
3. Patients with ECOG performance status 0-2
4. Patients with ASA PS 1-2
5. Preoperative Hgb ≥ 7 g/dL
6. Patients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC)
7. In case of showing proper organ function WBC ≥ 3,000/mm3 Platelets ≥ 100,000/mm3 Creatinine ≤ 2.0 mg/dL Bilirubin ≤ 1.5 x institutional upper limit normal SGOT, SGPT, and ALP ≤ 3 x institutional upper limit normal
8. Patient who voluntarily signed the informed consent form

Exclusion Criteria:

1. Patient who unable to determine whether or not to consent on their own
2. Patients with serious underlying diseases or complications
3. Women who are pregnant or lactating
4. Patients with concurrent infection
5. Patients who are allergic to existing iron preparations
6. Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy
7. Patients who have had or received cancer treatment within 5 years, except for non-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladder
8. Patients with iron overload or iron utilization disorders
9. Patients with serum ferritin > 800ng/mL or TSAT > 50% on Iron panel tests

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient blood management group; before surgery (within 2-6 weeks before surgery)- 7 ≤ Hb < 12 g/dL : ferric carboxymaltose 1000mg; during surgery- In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist; after surgery (POD #1)7 ≤ Hb < 12 g/dL : ferric carboxymaltose 1000mgHb <7 g/dL : pRBC 2 packs transfusion	Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml; ferric carboxymaltose 1000mg, fixed dose for intervention group
Active Comparator: conventional management group; before surgery (within 2-6 weeks before surgery)8 ≤ Hb < 10 g/dL: pRBC 1 pack transfusionHb < 8 g/dL: pRBC 2 packs transfusion * Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements); during surgery- In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist; after surgery (POD #1)8 ≤ Hb < 10 g/dL: pRBC 1 pack transfusionHb < 8 g/dL: pRBC 2 packs transfusion * Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements)	Drug: RBC; pack RBC transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transfusion rate	Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment	within 3 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin differences	Comparison of hemoglobin differences between the groups	within 3 weeks after surgery
Frequency of anemia	Frequency of anemia and blood transfusion before adjuvant therapy between the groups	within 3 weeks after surgery
Frequency and delay period of treatment	Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups	within 3 weeks after surgery
The costs that patients actually pay for treatment (Cost-effectiveness)	Investigate, evaluate, and compare the costs that patients actually pay for treatment between the two groups.	within 3 weeks after surgery
Quality of life of patients EORTC QLQ-C30	used to collect information on patients' quality of life and compare the scores of the two groups. Scores are given from 1 to 4 for most questions, and the lower the score, the better the patient's quality of life is evaluated. The average of the total scores is used to compare the two groups.	within 3 weeks after surgery
Adverse events	ADR (adverse drug reaction) is investigated between the two groups, and the rate of adverse reactions and the rate of moderate adverse reactions in each group are compared.	within 3 weeks after surgery
Quality of life of patients HINT-8	HINT-8 used to collect information on patients' quality of life and compare the scores of the two groups. Each answer is given to 8 questions, and each answer is scored and assigned from 1 to 4 points, and the averages of the two groups are also compared.	within 3 weeks after surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Jeong-Yeol Park, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: endometrial cancer; ovarian cancer; cervical cancer; patient blood management; IV iron
• Additional Relevant MeSH Terms: Hematinics; Ferric Compounds
• Other Study ID Numbers: 2022-1674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No