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

NCT ID: NCT04653181

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Randomized preoperative iron substitution for patient with iron deficient anemia

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iron arm

Half of patients get i.v. iron preoperatively

Group Type EXPERIMENTAL

Ferric carboxymaltose

Intervention Type DRUG

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

non-iron arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ferric carboxymaltose

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

Intervention Type DRUG

Other Intervention Names

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Ferinject (intravenous iron )

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Selja Koskensalo

Consultant, abdominal surgeon,Md, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selja K Koskensalo, Md, PhD

Role: STUDY_DIRECTOR

Abdominal centre, HUCH

Locations

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Jorvi Hospital

Espoo, HUS, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Suvi K Rasilainen, Md, PhD

Role: CONTACT

+35894711 ext. +358504271748

Facility Contacts

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Suvi K Rasilainen, Md, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21761412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26409561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26694926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31060656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12079143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15273542 (View on PubMed)

Other Identifiers

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SKoskensalo

Identifier Type: -

Identifier Source: org_study_id

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