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

NCT04653181 | Recruiting

• 1 other identifier: SKoskensalo
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Need for red blood cell transfusion

  30 days

Study Arms (2)

Iron arm

EXPERIMENTAL

Half of patients get i.v. iron preoperatively

Drug: Ferric carboxymaltose

non-iron arm

NO INTERVENTION

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

Interventions

Ferric carboxymaltose DRUG

Iron-arm treated with Ferric carboxymaltose, non-iron arm without

Also known as: Ferinject (intravenous iron )

Iron arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• hyperreactivity for Ferinject
• haemochromatosis
• refusal for participation

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Jorvi Hospital

Espoo, HUS, 00029, Finland

RECRUITING

Related Publications (6)

• 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.

  PMID: 21761412 BACKGROUND

• 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.

  PMID: 26409561 BACKGROUND

• 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.

  PMID: 26694926 BACKGROUND

• 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.

  PMID: 31060656 BACKGROUND

• 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.

  PMID: 12079143 BACKGROUND

• 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.

  PMID: 15273542 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Postoperative Complications

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Selja K Koskensalo, Md, PhD

  Abdominal centre, HUCH

  STUDY DIRECTOR

Central Study Contacts

Suvi K Rasilainen, Md, PhD

CONTACT

+35894711; suvi.rasilainen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, abdominal surgeon,Md, PhD

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 4, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)