Clinical trial NCT05669872: Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer
Official title: A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of Patient Blood Management Program in Patients With Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Keywords: endometrial cancer
ovarian cancer
cervical cancer
patient blood management
IV iron
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2023-01-03
Enrollment: 334
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: transfusion rate
timeFrame: within 3 weeks after surgery
Secondary outcomes:
measure: hemoglobin differences
timeFrame: within 3 weeks after surgery
measure: Frequency of anemia
timeFrame: within 3 weeks after surgery
measure: Frequency and delay period of treatment
timeFrame: within 3 weeks after surgery
measure: The costs that patients actually pay for treatment (Cost-effectiveness)
timeFrame: within 3 weeks after surgery
measure: Quality of life of patients EORTC QLQ-C30
timeFrame: within 3 weeks after surgery
measure: Adverse events
timeFrame: within 3 weeks after surgery
measure: Quality of life of patients HINT-8
timeFrame: within 3 weeks after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jeong-Yeol Park
role: PRINCIPAL_INVESTIGATOR
References: