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

Asan Medical Center

Status: Not yet enrolling

Conditions: Gynecologic Cancer

Treatments: Drug: RBC; Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml

Study type: Interventional

Funder types: Other

Identifiers

NCT05669872

2022-1674

Details and patient eligibility

About

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

Full 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.

Enrollment: 334 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

patient blood management group

Experimental group

Description:

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

Treatment:

Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml

conventional management group

Active Comparator group

Description:

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)

Treatment:

Drug: RBC