Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer

Gynecologic Cancer Clinical Trial

Official title:

A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of Patient Blood Management Program in Patients With Gynecologic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05669872
• Other study ID #: 2022-1674
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2023
• Source: Asan Medical Center
• Contact: Jeong-Yeol Park, M.D., Ph.D
• Phone: +821074748988
• Email: catgut1-0[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 334
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Drug:
• Ferric Carboxymaltose 50Mg/Ml Inj 20Ml
ferric carboxymaltose 1000mg, fixed dose for intervention group
• RBC
pack RBC transfusion

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transfusion rate	Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment	within 3 weeks after surgery
Secondary	hemoglobin differences	Comparison of hemoglobin differences between the groups	within 3 weeks after surgery
Secondary	Frequency of anemia	Frequency of anemia and blood transfusion before adjuvant therapy between the groups	within 3 weeks after surgery
Secondary	Frequency and delay period of treatment	Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups	within 3 weeks after surgery
Secondary	The costs that patients actually pay for treatment (Cost-effectiveness)	Investigate, evaluate, and compare the costs that patients actually pay for treatment between the two groups.	within 3 weeks after surgery
Secondary	Quality of life of patients EORTC QLQ-C30	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.	within 3 weeks after surgery
Secondary	Adverse events	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.	within 3 weeks after surgery
Secondary	Quality of life of patients HINT-8	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.	within 3 weeks after surgery