Magnet

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)...

Trial Status Closed
Phase
Type of cancer Colorectal carcinoma
Study design

Randomised, parallel group multi-centre study; Arms; No crossover group; Placebo controlled;

Objectives

Primary 

  • To evaluate the efficacy and tolerability of magnesium gluconate 3 g bid. given orally to modulate magnesium wasting in patients with colorectal cancer treated with EGFR targeted antibody therapy.
  • To evaluate the efficacy and tolerability of magnesium gluconate 3 g six times per day compared to 3 g bid. given orally to modulate magnesium wasting in patients with colorectal cancer with grade 1 hypomagnesemia induced by EGFR targeted antibody therapy.

Secondary

  • To measure compliance to magnesium supplementation regimens.
  • To measure the impact of magnesium supplementation on asthenia and Quality-of-Life.
Inclusion Main criteria

Subjects with colorectal cancer in whom treatment with anti-EGFR targeted antibodies is being started.

Male or female subjects aged between 18 and 80 years

Exclusion Main 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
Treatment schedule

Randomisation will be performed centrally using a set of consecutively numbered sealed envelopes containing the treatment arm code according to a predetermined, computer generated random table. The study medication will be provided at each investigational site. Upon randomisation of part 1, patients will either receive no medication or 28 sachets of magnesium gluconate 3g every two weeks. Stratification for combination therapy with oxaliplatin will be performed. In part 2, patients will be provided with 28 or 84 sachets of magnesium gluconate 3 every two weeks. If anti-EGFR treatment has to be postponed, for any reason, patients will be asked to continue their study drug at the same dosage.

Study Period

Date of beginning of study: (First patient in). Last patient in. Date of end of study: (Last patient out).

Study Coordinators

Sabine Tejpar; Hubert Piessevaux;

Participating Groups

BGDO

Participating centres

UZ Leuven - S. Tejpar Algemene Kliniek St.-Jan - Brussel - Dr. P. Van Maele AZ Damiaan - Oostende - Dr. G. Deboever AZ KLINA - Brasschaat - Dr. W. Demey AZ Maria Middelares - Gent - Dr. E. Monsaert AZ Sint Jozef - Malle - Dr. W. Demey AZ Sint Maarten - Mechelen - Dr. M. Ferrante AZ St Jan AV - Brugge - Dr. A. Bols AZ St-Jan - Brugge - Dr. J. Arts C.H.U. Sart-Tilman - Liège - Dr. M. Polus CHPLT - Verviers - Dr. Hassan Kalantari Cliniques Universitaires Saint Luc - Brussels - Prof. Y Humblet H.-Hartziekenhuis vzw Roeselare-Menen - Dr. G. Ghillebert Sint Augustinusziekenhuis - Wilrijk - Dr. F. Van de Mierop Sint-Jozefkliniek Bornem-Willebroek - Bornem - Dr. T. Rondou St Elisabeth Ziekenhuis - Turnhout - Dr. J. Janssens ULB Erasme - Brussels - Dr. A. Demols UMT site RHMS/CHWAPI Tournai - Dr. K. Kargar Samani UZ Antwerpen - Prof. M. Peeters UZ Gent - Dr. S. Laurent

Protocol summary Link to ClinicalTrials.gov
NCT number
EudraCT 2007-001131-61
Interest to participate clinicaltrials@bgdo.org
More info clinicaltrials@bgdo.org