Gynecologic CancerNCT05669872
Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer
A study testing Ferric Carboxymaltose 50Mg/Ml Inj 20Ml and RBC in people with Gynecologic Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Ferric Carboxymaltose 50Mg/Ml Inj 20Ml and RBC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 20-80 years
- Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer)
- Patients with ECOG performance status 0-2
- Patients with ASA PS 1-2
- Preoperative Hgb ≥ 7 g/dL
- Patients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC)
- 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
- Patient who voluntarily signed the informed consent form
Who cannot join
- Patient who unable to determine whether or not to consent on their own
- Patients with serious underlying diseases or complications
- Women who are pregnant or lactating
- Patients with concurrent infection
- Patients who are allergic to existing iron preparations
- Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy
Show all 9Show fewer
- 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
- Patients with iron overload or iron utilization disorders
- Patients with serum ferritin > 800ng/mL or TSAT > 50% on Iron panel tests
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
About this study
Official title: A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of Patient Blood Management Program in Patients With Gynecologic Cancer
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.
- Conditions
- Gynecologic Cancer
- Being tested
- Ferric Carboxymaltose 50Mg/Ml Inj 20Ml, RBC
- Keywords
- endometrial cancer, ovarian cancer, cervical cancer, patient blood management, IV iron
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose 50Mg/Ml Inj 20MlDrug
ferric carboxymaltose 1000mg, fixed dose for intervention group
RBCDrug
pack RBC transfusion
| Study group | Role | What they receive |
|---|---|---|
| patient blood management group | Experimental | 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 Receives: Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml |
| conventional management group | Active comparator | 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) Receives: Drug: RBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
transfusion rate
Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment
Measured: within 3 weeks after surgery
Secondary outcomes (7)
hemoglobin differences
Comparison of hemoglobin differences between the groups
Measured: within 3 weeks after surgery
Frequency of anemia
Frequency of anemia and blood transfusion before adjuvant therapy between the groups
Measured: within 3 weeks after surgery
Frequency and delay period of treatment
Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups
Measured: within 3 weeks after surgery
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.
Measured: within 3 weeks after surgery
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.
Measured: within 3 weeks after surgery
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.
Measured: within 3 weeks after surgery
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.
Measured: within 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Yeol Park, MD, PhD, Asan Medical Center
- Investigators
- Jeong-Yeol Park, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669872
- Sponsor's protocol ID
- 2022-1674
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park JY, Kang OJ, Lee YY, Kim YS. A prospective randomized controlled trial evaluating the safety and efficacy of patient blood management program in patients with gynecologic cancer (KGOG 4011/PBM). Int J Gynecol Cancer. 2023 Jul 3;33(7):1140-1144. doi: 10.1136/ijgc-2023-004403.
PubMed 37094968
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of Patient Blood Management Program in Patients With Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT05669872
- Acronym / sponsor ID
- 2022-1674
- Conditions
- Gynecologic Cancer
- Keywords
- endometrial cancer, ovarian cancer, cervical cancer, patient blood management, IV iron
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient blood management group | Experimental | Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml1. 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 |
| conventional management group | Active comparator | Drug: RBC1. 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) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged 20-80 years
- Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer)
- Patients with ECOG performance status 0-2
- Patients with ASA PS 1-2
- Preoperative Hgb ≥ 7 g/dL
Key exclusion criteria (9 listed)
- Patient who unable to determine whether or not to consent on their own
- Patients with serious underlying diseases or complications
- Women who are pregnant or lactating
- Patients with concurrent infection
- Patients who are allergic to existing iron preparations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose 50Mg/Ml Inj 20Mlferric carboxymaltose 1000mg, fixed dose for intervention group | Drug | patient blood management group |
| RBCpack RBC transfusion | Drug | conventional management group |
Primary outcome
transfusion rate
Time frame: within 3 weeks after surgery
Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment
7 secondary outcomes
hemoglobin differences
Time frame: within 3 weeks after surgery
Frequency of anemia
Time frame: within 3 weeks after surgery
Frequency and delay period of treatment
Time frame: within 3 weeks after surgery
The costs that patients actually pay for treatment (Cost-effectiveness)
Time frame: within 3 weeks after surgery
Quality of life of patients EORTC QLQ-C30
Time frame: within 3 weeks after surgery
Adverse events
Time frame: within 3 weeks after surgery
Quality of life of patients HINT-8
Time frame: within 3 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 37094968Park JY, Kang OJ, Lee YY, Kim YS. A prospective randomized controlled trial evaluating the safety and efficacy of patient blood management program in patients with gynecologic cancer (KGOG 4011/PBM). Int J Gynecol Cancer. 2023 Jul 3;33(7):1140-1144. doi: 10.1136/ijgc-2023-004403.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Yeol Park principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferric Carboxymaltose 50Mg/Ml Inj 20Ml and RBC in people with Gynecologic Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Yeol Park, M.D., Ph.D (+821074748988, catgut1-0@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transfusion rate (time frame: within 3 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.