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Randomized Controlled Trial Comparing Intravenous Ferric Carboxymaltose Versus Oral Ferrous Fumarate for the Treatment of Anemia in Cancer Patients Undergoing Major Elective Surgery

Randomized Controlled Trial Comparing Intravenous Iron Sucrose Versus Oral Ferrous Fumarate for the Treatment of Anemia in Cancer Patients Undergoing Major Elective Surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251229004
Enrollment
104
Registered
2025-12-29
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The increased of hemoglobin level compared between giving iron sucrose vs ferrous fumarate in patients with cancer, ongoing elective surgery preoperative, iron deficiency anemia, cancer, iron supplement, iron sucrose, ferrous fumarate

Interventions

Patients receiving iron sucrose will receive 200 mg per times, trice weekly, until the participants received target dose The dosage of iron sucrose is calculated by 2.4 x body weight (kg) x (target H
Experimental Drug,Active Comparator Drug
iron sucrose,Ferrous fumarate

Sponsors

Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria - Age 20-80 years, which diagnosed with cancer, or suspicious of cancer - Hemoglobin level < 10 g/dL - Patients got iron deficiency status, which can be classify into 2 groups; - Absolute IDA: ferritin < 30, and %T-sat < 20% - Functional IDA: ferritin 30-300 and %T-sat < 20% - Patients should receive iron supplementation at least two weeks prior to surgery. - Patients should go on surgical procedure that classify in high bleeding risk, according to 2022 ESC guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery - Research participants or their legally authorized representatives may provide consent to participate in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria - Using erythropoiesis stimulating agent during admission, or within 3 months before enrolment - Receiving blood components, or blood product within 1 month before enrolment - The surgical procedure is not palliative surgery - eGFR < 30 mL/min/1.73 m2 - AST and/or ALT higher than 3 times above upper normal limits - Patients whose diagnosed with thalassemia disease - Patients were diagnosed with hematologic malignancies - The patient or their legally authorized representative may refuse to provide consent.

Design outcomes

Primary

MeasureTime frame
The increased of hemoglobin level 14 days after intervention Hemoglobin level from complete blood count

Secondary

MeasureTime frame
length of stay in hospital from date of admission to date of discharge length of stay during admission for surgical procedure,ferritin level at date of pre-operative 14 days after intervention ferritin level at date before surgery,Change of hemoglobin level after 30 days post-operatively within 45 days after intervention (post-operative 30 days) hemoglobin level,Hemoglobin level pre-operative 14 days after intervention Hemoglobin level at date before surgery,Number of blood transfusion needed during intervention from date of enrollment to 45 days after intervention number of blood transfusion during intervention,Complications after surgery From date of operation to 30 days post-operation rate of readmission, other complication noted in OPD card of patient,rate of ICU admission during admission from date of admission for surgery to discharge date rate of transfer to intensive care during admission for surgery

Countries

Thailand

Contacts

Public ContactWoramek Manosithisak

Division of Hematology, Department of Internal Medicine, Chiang Mai University

woramek.mano@cmu.ac.th0800477772

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026