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Preoperative i.v. Iron Substitution in Patients With Colon Cancer (PREFECO)

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Ferric carboxymaltose
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring postoperative complications

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age> 18 years
  • Dg: Colon ca
  • The planned measure: the colon resection
  • Men: Hb <130, women: Hb <120 and iron deficiency (elevated TfR, low TrFesat or low ferritin)

Exclusion Criteria:

  • hyperreactivity for Ferinject
  • haemochromatosis
  • refusal for participation

Sites / Locations

  • Jorvi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Iron arm

non-iron arm

Arm Description

Half of patients get i.v. iron preoperatively

Half of patients are treated without i.v. iron substitution

Outcomes

Primary Outcome Measures

postoperative complications
At study, difference between arms will be evaluated: Complications are analysed using Clavien-Dindo classification https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360123/bin/3TT1.jpg

Secondary Outcome Measures

Need for red blood cell transfusion
Number of Participants in need for red blood cells transfusion per arm

Full Information

First Posted
November 19, 2020
Last Updated
March 16, 2022
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04653181
Brief Title
Preoperative i.v. Iron Substitution in Patients With Colon Cancer
Acronym
PREFECO
Official Title
Preoperative i.v. Iron Substitution in Patients With Colon Carcinoma and Iron-deficiency Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
About 70% of colon cancer patients are anemic. Preoperative anemia in patients with colorectal cancer is associated with both impaired disease-free survival and overall survival. The purpose of this study is to compare the effects of preoperative iv iron substitution on postoperative recovery in preoperatively anemic (male Hb <130, female Hb <120) and iron deficient colon cancer patients in a prospective setup. As a primary outcome, the effect of iv-iron substitution on postoperative complications is investigated.
Detailed Description
Randomized preoperative iron substitution for patient with iron deficient anemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
postoperative complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
514 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iron arm
Arm Type
Experimental
Arm Description
Half of patients get i.v. iron preoperatively
Arm Title
non-iron arm
Arm Type
No Intervention
Arm Description
Half of patients are treated without i.v. iron substitution
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose
Other Intervention Name(s)
Ferinject (intravenous iron )
Intervention Description
Iron-arm treated with Ferric carboxymaltose, non-iron arm without
Primary Outcome Measure Information:
Title
postoperative complications
Description
At study, difference between arms will be evaluated: Complications are analysed using Clavien-Dindo classification https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360123/bin/3TT1.jpg
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Need for red blood cell transfusion
Description
Number of Participants in need for red blood cells transfusion per arm
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age> 18 years Dg: Colon ca The planned measure: the colon resection Men: Hb <130, women: Hb <120 and iron deficiency (elevated TfR, low TrFesat or low ferritin) Exclusion Criteria: hyperreactivity for Ferinject haemochromatosis refusal for participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suvi K Rasilainen, Md, PhD
Phone
+35894711
Ext
+358504271748
Email
suvi.rasilainen@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selja K Koskensalo, Md, PhD
Organizational Affiliation
Abdominal centre, HUCH
Official's Role
Study Director
Facility Information:
Facility Name
Jorvi Hospital
City
Espoo
State/Province
HUS
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suvi K Rasilainen, Md, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21761412
Citation
Zhen L, Zhe S, Zhenning W, Zhifeng M, Zhidong L, Xiaoxia L, Jianguang Y, Huimian X. Iron-deficiency anemia: a predictor of diminished disease-free survival of T3N0M0 stage colon cancer. J Surg Oncol. 2012 Mar 15;105(4):371-5. doi: 10.1002/jso.22032. Epub 2011 Jul 14.
Results Reference
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PubMed Identifier
26409561
Citation
Calvet X, Gene E, AngelRuiz M, Figuerola A, Villoria A, Cucala M, Mearin F, Delgado S, Calleja JL. Cost-minimization analysis favours intravenous ferric carboxymaltose over ferric sucrose or oral iron as preoperative treatment in patients with colon cancer and iron deficiency anaemia. Technol Health Care. 2016;24(1):111-20. doi: 10.3233/THC-151074.
Results Reference
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PubMed Identifier
26694926
Citation
Calleja JL, Delgado S, del Val A, Hervas A, Larraona JL, Teran A, Cucala M, Mearin F; Colon Cancer Study Group. Ferric carboxymaltose reduces transfusions and hospital stay in patients with colon cancer and anemia. Int J Colorectal Dis. 2016 Mar;31(3):543-51. doi: 10.1007/s00384-015-2461-x. Epub 2015 Dec 22.
Results Reference
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PubMed Identifier
31060656
Citation
Ristescu I, Pintilie G, Filip D, Jitca M, Fecheta R, Florescu I, Scripcariu V, Filipescu D, Grigoras I. Perioperative Anemia and Transfusion in Colorectal Cancer Patients. Chirurgia (Bucur). 2019 Mar-Apr;114(2):234-242. doi: 10.21614/chirurgia.114.2.234.
Results Reference
background
PubMed Identifier
12079143
Citation
Dunne JR, Gannon CJ, Osborn TM, Taylor MD, Malone DL, Napolitano LM. Preoperative anemia in colon cancer: assessment of risk factors. Am Surg. 2002 Jun;68(6):582-7.
Results Reference
background
PubMed Identifier
15273542
Citation
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Results Reference
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Preoperative i.v. Iron Substitution in Patients With Colon Cancer

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