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

Not Applicable

Not yet recruiting

• Conditions: Gynecologic Cancer
• Interventions: Drug: RBC; Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml

• Registration Number: NCT05669872
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-12-30
• Status Verified: 2023-01
• Study First Posted: 2023-01-03
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-05
• Study Start: 2023-02
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 334

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional management group	RBC	1. 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) 2. during surgery - In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist 3. 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)
patient blood management group	Ferric Carboxymaltose 50Mg/Ml Inj 20Ml	1. before surgery (within 2-6 weeks before surgery) - 7 ≤ Hb \< 12 g/dL : ferric carboxymaltose 1000mg 2. during surgery - In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist 3. after surgery (POD #1) * 7 ≤ Hb \< 12 g/dL : ferric carboxymaltose 1000mg * Hb \<7 g/dL : pRBC 2 packs transfusion

Primary Outcome Measures

Name	Time	Method
transfusion rate	within 3 weeks after surgery	Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment

Secondary Outcome Measures

Name	Time	Method
Quality of life of patients EORTC QLQ-C30	within 3 weeks after surgery	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.
Quality of life of patients HINT-8	within 3 weeks after surgery	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.
hemoglobin differences	within 3 weeks after surgery	Comparison of hemoglobin differences between the groups
Frequency of anemia	within 3 weeks after surgery	Frequency of anemia and blood transfusion before adjuvant therapy between the groups
Frequency and delay period of treatment	within 3 weeks after surgery	Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups
The costs that patients actually pay for treatment (Cost-effectiveness)	within 3 weeks after surgery	Investigate, evaluate, and compare the costs that patients actually pay for treatment between the two groups.
Adverse events	within 3 weeks after surgery	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.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of