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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

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