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Trial Title:
Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer
NCT ID:
NCT05669872
Condition:
Gynecologic Cancer
Conditions: Official terms:
Ferric Compounds
Conditions: Keywords:
endometrial cancer
ovarian cancer
cervical cancer
patient blood management
IV iron
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ferric Carboxymaltose 50Mg/Ml Inj 20Ml
Description:
ferric carboxymaltose 1000mg, fixed dose for intervention group
Arm group label:
patient blood management group
Intervention type:
Drug
Intervention name:
RBC
Description:
pack RBC transfusion
Arm group label:
conventional management group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Start date:
February 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Asan Medical Center
Agency class:
Other
Source:
Asan Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05669872
