A prospective randomized controlled trial evaluating the safety and efficacy of patient blood management program in patients with gynecologic cancer

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0008092
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 334

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transfusion rate within 3 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Treatment related adverse events ;Comparison of hemoglobin differences between the groups;Frequency of anemia and blood transfusion before adjuvant therapy between the groups;Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups;Differences in quality of life of between the groups;Cost-effectiveness differences of between the groups