Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer
Study Details
Study Description
Brief Summary
To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 1000mg Hb <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 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
pack RBC transfusion
|
Outcome Measures
Primary Outcome Measures
- transfusion rate [within 3 weeks after surgery]
Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
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)
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Patients with ECOG performance status 0-2
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Patients with ASA PS 1-2
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Preoperative Hgb ≥ 7 g/dL
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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
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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
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Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy
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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
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Patients with serum ferritin > 800ng/mL or TSAT > 50% on Iron panel tests
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center | Seoul | Korea, Republic of | 138-736 |
Sponsors and Collaborators
- Asan Medical Center
Investigators
- Principal Investigator: Jeong-Yeol Park, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-1674