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

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

Detailed Description
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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.

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

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml
* Drug: RBC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 20-80 years Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer) Patients with ECOG performance status 0-2 Patients with ASA PS 1-2 Preoperative Hgb ≥ 7 g/dL Patients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC) 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 Patient who voluntarily signed the informed consent form Exclusion Criteria: Patient who unable to determine whether or not to consent on their own Patients with serious underlying diseases or complications Women who are pregnant or lactating Patients with concurrent infection Patients who are allergic to existing iron preparations Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy 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 Patients with iron overload or iron utilization disorders Patients with serum ferritin > 800ng/mL or TSAT > 50% on Iron panel tests

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient blood management group<br>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 1000mg Hb <7 g/dL : pRBC 2 packs transfusion | Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml<br>* ferric carboxymaltose 1000mg, fixed dose for intervention group<br>|
| Active Comparator: conventional management group<br>before surgery (within 2-6 weeks before surgery) 8 ≤ Hb < 10 g/dL: pRBC 1 pack transfusion Hb < 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 transfusion Hb < 8 g/dL: pRBC 2 packs transfusion * Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements) | Drug: RBC<br>* pack RBC transfusion<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial cancer, ovarian cancer, cervical cancer, patient blood management, IV iron