Effects of intravenous administered iron in non-anemic iron deficient patients with colorectal cancer.

Phase 1

• Conditions: Iron-deficiency in colorectal cancer; MedDRA version: 20.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003819-56-DK
• Lead Sponsor: Centre for Surgical Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-06
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Inclusion criteria
-Planned for curative intended elective colon or rectum cancer surgery
-UICC stage I-III
-Age = 18
-Hgb > 7.0 for both men and women
-Serum ferritin =100 µg/L for both men and women

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67

Exclusion Criteria

-Chronic kidney failure, with need for dialysis
-Metachronous diagnosed cancer
-Unable to speak and understand Danish
-Cognitive impairment e.g. moderate to severe dementia
-Severe active infection
-Known allergy of monofer
-Contraindication for iv. iron infusion
-Withdrawal of informed consent
-Neoadjuvant chemo or radiation therapy
- Pregnant women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified