Preoperative i.v. Iron Substitution in Patients With Colon Cancer

Colon Cancer Clinical Trial

— PREFECO  

Official title:

Preoperative i.v. Iron Substitution in Patients With Colon Carcinoma and Iron-deficiency Anemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653181
• Other study ID #: SKoskensalo
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Helsinki University Central Hospital
• Contact: Suvi K Rasilainen, Md, PhD
• Phone: +35894711
• Email: suvi.rasilainen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized preoperative iron substitution for patient with iron deficient anemia

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 514
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• Ferric carboxymaltose
Iron-arm treated with Ferric carboxymaltose, non-iron arm without

Locations

Country	Name	City	State
Finland	Jorvi Hospital	Espoo	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	Need for red blood cell transfusion	Number of Participants in need for red blood cells transfusion per arm	30 days