A national randomised multi-centre trial to assess the effect of oral magnesium supplementation on the kinetics of magnesium wasting induced by EGFR targeted antibody therapy for colorectal carcinoma (the MAGNET trial). - MAGNET

Phase 1

Active, not recruiting

• Conditions: To evaluate the effect and tolerability of high dose Mg gluconate oral substitution in the (1) prevention and (2) treatment of magnesium wasting due to anti-EGFR treatment in colorectal cancer; MedDRA version: 9.1Level: LLTClassification code 10005654Term: Blood magnesium decreased

• Registration Number: EUCTR2007-001131-61-BE
• Lead Sponsor: Belgian Group of Digestive Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-17
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Subjects with colorectal cancer in whom treatment with anti-EGFR targeted antibodies is being started in the metastatic or adjuvant setting.
2.Subjects must provide written witnessed informed consent prior to any study procedures being performed
3.Male or female subjects aged between 18 and 80 years
4.Subjects must be able to understand the study, comply with the study requirements and return to the investigational site for assessments at specified times

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects treated with cisplatin based chemotherapy within 6 months prior to inclusion
2.Subjects with renal failure, i.e. creatinine levels > 2 mg/dl or creatinine clearance < 50 mg/dl
3.Subjects with baseline hypomagnesemia
4.Subjects with baseline diarrhea, i.e. > 4 bowel movements/day
5.Subjects with known intolerance to magnesium supplementation
6.Subjects with short bowel
7.Subjects with known or impending bowel obstruction

Study & Design

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