Intravenous versus oral iron supplementation for anemic patients with rectal cancer undergoing preoperative chemoradiotherapy

Intravenous versus oral iron supplementation for iron deficiency anemia in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy: A prospective randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0009260

Enrollment

Registered

2024-03-21

Start date

2024-05-14

Completion date

Unknown

Last updated

2024-07-23

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

Conditions

None listed

Interventions

Drug : ? Intravenous iron supplements - Ferinject Inj (JW Pharmaceutical) 10ml : Ferric Hydroxide Carboxymaltose complex : 50mg iron/ml : Intravenous iron supplement for iron deficienc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with primary rectal cancer without distant metastases - Age 20 or older - patients who agree to participate in this study and sign the clinical trial consent form - Iron deficiency anemia : Hemoglobin <12g/dL for women, hemoglobin <13g/dL for men Serum ferritin <30 ng/mL Serum transferrin saturation (TSAT) <20% - Patients scheduled to receive neoadjuvant chemotherapy

Exclusion criteria

Exclusion criteria: - requiring emergency surgery due to obstruction, perforation, etc. - received a blood transfusion within 1 month of screening - Serum ferritin >800 ng/mL - pregnant woman - contraindicated in the use of Perinect Injection or Ferovayl Released Tablet - ASA score >3 - If erythropoietin stimulating agent was used within 3 months of screening - Chronic renal disease (Glomerular filtration rate <30 ml/min/m) - Increased serum AST (GOT) and ALT (GPT) (more than 3 times normal) - Myelodysplastic sybdrome - hereditary hemochromatosis - thalassemia - Hemolytic anemia - History of abdominal surgery (The following do not meet the exclusion criteria: appendectomy, cholecystectomy, benign gynecological surgery – oophorectomy, cesarean section, simple hysterectomy for myoma)

Design outcomes

Primary

Measure	Time frame
Proportion of patients with normalized serum hemoglobin	—

Secondary

Measure	Time frame
Serum hemoglobin, iron assay (ferritin, iron, TIBC [total iron binding capacity]), time taken to normalize serum hemoglobin, blood transfusion, complications, length of stay	—

Countries

Korea, Republic of

Contacts

Public ContactHyeung-min Park

Chonnam National University Hospital Hwasun Hospital

smart-1023@hanmail.net+82-61-379-7646

Outcome results