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

Primary Purpose

Gastric Cancer, Anemia, Surgery

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ferric carboxymaltose
Placebos
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Placebo

    Arm Description

    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.

    Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug

    Outcomes

    Primary Outcome Measures

    The need for blood transfusion
    Number of patients needing transfusions

    Secondary Outcome Measures

    Postoperative complications
    Postoperative complications measured using Comprehensive complication index
    Patients' quality of life (RAND)
    RAND questionnaires
    Patients' quality of life (15D)
    15D questionnaires
    Patients' quality of life (EQ-5D)
    EQ-5D questionnaires
    Patients' quality of life (FRAIL)
    FRAIL questionnaires
    Patients' quality of life (PRISMA-7)
    PRISMA-7 questionnaires
    Patients' quality of life (GSRS)
    GSRS questionnaires
    Patients' quality of life (IDQ)
    IDQ questionnaires
    Patients' haemoglobin and iron parameter levels
    Patients' haemoglobin and iron parameter levels
    Patients' haemoglobin and iron parameter levels
    Patients' haemoglobin and iron parameter levels
    Patients' haemoglobin and iron parameter levels
    Patients' haemoglobin and iron parameter levels
    Re-admission
    Patient re-admission rates
    90-day mortality
    90-day mortality
    Overall survival
    Overall survival
    Length of hospital stay
    Length of hospital stay
    Use of IV iron after operation
    Number of doses and median dose of IV iron

    Full Information

    First Posted
    November 12, 2019
    Last Updated
    November 16, 2019
    Sponsor
    Helsinki University Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04168346
    Brief Title
    Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
    Acronym
    IRONSTOMACH
    Official Title
    Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    November 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    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

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, Anemia, Surgery, Iron Deficiency Anemia, Surgery--Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    202 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug
    Intervention Type
    Drug
    Intervention Name(s)
    Ferric carboxymaltose
    Intervention Description
    Ferric carboxymaltose iv infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    NaCl 0.9% infusion
    Primary Outcome Measure Information:
    Title
    The need for blood transfusion
    Description
    Number of patients needing transfusions
    Time Frame
    Within 30 days from the day of the operation
    Secondary Outcome Measure Information:
    Title
    Postoperative complications
    Description
    Postoperative complications measured using Comprehensive complication index
    Time Frame
    Within 30 days from operation
    Title
    Patients' quality of life (RAND)
    Description
    RAND questionnaires
    Time Frame
    One and six months after the surgery
    Title
    Patients' quality of life (15D)
    Description
    15D questionnaires
    Time Frame
    One and six months after the surgery
    Title
    Patients' quality of life (EQ-5D)
    Description
    EQ-5D questionnaires
    Time Frame
    One and six months after the surgery
    Title
    Patients' quality of life (FRAIL)
    Description
    FRAIL questionnaires
    Time Frame
    One and six months after the surgery
    Title
    Patients' quality of life (PRISMA-7)
    Description
    PRISMA-7 questionnaires
    Time Frame
    One and six months after the surgery
    Title
    Patients' quality of life (GSRS)
    Description
    GSRS questionnaires
    Time Frame
    One and six months after the surgery
    Title
    Patients' quality of life (IDQ)
    Description
    IDQ questionnaires
    Time Frame
    One and six months after the surgery
    Title
    Patients' haemoglobin and iron parameter levels
    Description
    Patients' haemoglobin and iron parameter levels
    Time Frame
    At the time of hospital discharge (estimated on average 10 days after surgery)
    Title
    Patients' haemoglobin and iron parameter levels
    Description
    Patients' haemoglobin and iron parameter levels
    Time Frame
    One month after the surgery
    Title
    Patients' haemoglobin and iron parameter levels
    Description
    Patients' haemoglobin and iron parameter levels
    Time Frame
    Three months after the surgery
    Title
    Re-admission
    Description
    Patient re-admission rates
    Time Frame
    30 days after discharge from hospital
    Title
    90-day mortality
    Description
    90-day mortality
    Time Frame
    Within 90 days from operation
    Title
    Overall survival
    Description
    Overall survival
    Time Frame
    1, 3 and 5 years from operation
    Title
    Length of hospital stay
    Description
    Length of hospital stay
    Time Frame
    Within hospital stay, on average 7 - 14 days
    Title
    Use of IV iron after operation
    Description
    Number of doses and median dose of IV iron
    Time Frame
    Within 3 months from operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arto Kokkola, MD
    Phone
    +358-9-4711
    Email
    arto.kokkola@hus.fi
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arto Kokkola, MD
    Organizational Affiliation
    Helsinki University Central Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

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