Gynecologic Cancer
Conditions
Keywords
endometrial cancer, ovarian cancer, cervical cancer, patient blood management, IV iron
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.
Interventions
DRUGFerric Carboxymaltose 50Mg/Ml Inj 20Ml
ferric carboxymaltose 1000mg, fixed dose for intervention group
DRUGRBC
pack RBC transfusion
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| transfusion rate | within 3 weeks after surgery | Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| hemoglobin differences | within 3 weeks after surgery | Comparison of hemoglobin differences between the 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. |
| 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. |
Countries
South Korea
Contacts
Primary ContactJeong-Yeol Park, M.D., Ph.D
Backup ContactOk Ju Kang, M.D.
Outcome results
None listed