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Not yet recruitingNCT05669872Updated Jan 5, 2023

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

An interventional study of Ferric Carboxymaltose 50Mg/Ml Inj 20Ml and RBC in Gynecologic Cancer, sponsored by Asan Medical Center. Not yet recruiting at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-05.

Sponsored by Asan Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
334
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gynecologic Cancer

Keywords

  • endometrial cancer
  • ovarian cancer
  • cervical cancer
  • patient blood management
  • IV iron
03

In context

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
334 participants (estimated)

Study arms

  • Experimental
    patient blood management group

    1. before surgery (within 2-6 weeks before surgery) - 7 ≤ Hb \< 12 g/dL : ferric carboxymaltose 1000mg 2. during surgery - In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist 3. after surgery (POD #1) * 7 ≤ Hb \< 12 g/dL : ferric carboxymaltose 1000mg * Hb \<7 g/dL : pRBC 2 packs transfusion

    Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml

  • Active comparator
    conventional management group

    1. before surgery (within 2-6 weeks before surgery) * 8 ≤ Hb \< 10 g/dL: pRBC 1 pack transfusion * Hb \< 8 g/dL: pRBC 2 packs transfusion \* Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements) 2. during surgery - In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist 3. after surgery (POD #1) * 8 ≤ Hb \< 10 g/dL: pRBC 1 pack transfusion * Hb \< 8 g/dL: pRBC 2 packs transfusion \* Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements)

    Drug: RBC

Interventions

  • DrugFerric Carboxymaltose 50Mg/Ml Inj 20Ml

    ferric carboxymaltose 1000mg, fixed dose for intervention group

  • DrugRBC

    pack RBC transfusion

06

What researchers measure

Primary outcomes

  1. transfusion rate

    Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment

    Time frame: within 3 weeks after surgery

Secondary outcomes

  1. hemoglobin differences

    Comparison of hemoglobin differences between the groups

    Time frame: within 3 weeks after surgery

  2. Frequency of anemia

    Frequency of anemia and blood transfusion before adjuvant therapy between the groups

    Time frame: within 3 weeks after surgery

  3. Frequency and delay period of treatment

    Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups

    Time frame: within 3 weeks after surgery

  4. 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.

    Time frame: within 3 weeks after surgery

  5. 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.

    Time frame: within 3 weeks after surgery

  6. 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.

    Time frame: within 3 weeks after surgery

  7. 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.

    Time frame: within 3 weeks after surgery

07

Study locations

1 site
  • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
    Seoul, 138-736, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05669872
Lead sponsor
Asan Medical Center
Responsible party
Jeong-Yeol Park, MD, PhD (Professor, Asan Medical Center) — Principal investigator
First posted
Jan 3, 2023
Start date
Feb 2023 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 5, 2023

Study contacts

Jeong-Yeol Park, M.D., Ph.D
Contact
catgut1-0@hanmail.net
+821074748988
Ok Ju Kang, M.D.
Contact
lalala1301@gmail.com
82-10-2320-5499
Jeong-Yeol Park
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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