Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer (IRONSTOMACH)

The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia; Gastric Cancer; Surgery; Iron Deficiency Anemia; Surgery--Complications
• Intervention / Treatment: Drug: Ferric carboxymaltose; Drug: Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 202
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Arto Kokkola, MD; Phone Number: +358-9-4711; Email: arto.kokkola@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Patients with gastric cancer who will undergo a gastrectomy

Exclusion Criteria:

• Patients under 18 years old
• Patients not in full understanding
• Hemoglobin levels > 155 g/l for women and >167 g/l for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively.
• Transferrin saturation level >50%
• Emergency gastrectomy
• Palliative gastrectomy
• Acute bacterial infection
• Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products
• Clinical evidence of iron overload or disturbances in the utilisation of iron
• Patients <35 kg
• Dialysis therapy for chronic renal failure
• Hemochromatosis
• Polycythemia vera
• Pregnancy
• Patients in need of direct blood transfusion ( Criteria for this are hemoglobin < 80 g/l or < 90 g/l if the patient is symptomatic or has a history of heart disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; IV-iron substitution: The intravenous iron formulation used in the study is ferric carboxymaltose and it will be administered two to four weeks before the surgery, aiming at four weeks. The dose of intravenous iron will be calculated according to the weight and haemoglobin level of the patients, however so that all the patients receive minimum 1000mg iv iron and the maximum dose is 20 mg/kg per day.	Drug: Ferric carboxymaltose; Ferric carboxymaltose iv infusion
Placebo Comparator: Placebo; Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug	Drug: Placebos; NaCl 0.9% infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for blood transfusion	Number of patients needing transfusions	Within 30 days from the day of the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications measured using Comprehensive complication index	Within 30 days from operation
Patients' quality of life (RAND)	RAND questionnaires	One and six months after the surgery
Patients' quality of life (15D)	15D questionnaires	One and six months after the surgery
Patients' quality of life (EQ-5D)	EQ-5D questionnaires	One and six months after the surgery
Patients' quality of life (FRAIL)	FRAIL questionnaires	One and six months after the surgery
Patients' quality of life (PRISMA-7)	PRISMA-7 questionnaires	One and six months after the surgery
Patients' quality of life (GSRS)	GSRS questionnaires	One and six months after the surgery
Patients' quality of life (IDQ)	IDQ questionnaires	One and six months after the surgery
Patients' haemoglobin and iron parameter levels	Patients' haemoglobin and iron parameter levels	At the time of hospital discharge (estimated on average 10 days after surgery)
Patients' haemoglobin and iron parameter levels	Patients' haemoglobin and iron parameter levels	One month after the surgery
Patients' haemoglobin and iron parameter levels	Patients' haemoglobin and iron parameter levels	Three months after the surgery
Re-admission	Patient re-admission rates	30 days after discharge from hospital
90-day mortality	90-day mortality	Within 90 days from operation
Overall survival	Overall survival	1, 3 and 5 years from operation
Length of hospital stay	Length of hospital stay	Within hospital stay, on average 7 - 14 days
Use of IV iron after operation	Number of doses and median dose of IV iron	Within 3 months from operation

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Arto Kokkola, MD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 16, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 16, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Stomach Neoplasms; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: HUS/333/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No