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: 9.1 Level: LLT Classification code 10005654 Term: Blood magnesium decreased
Conditions
Interventions
Trade Name: Ultra Mg
Pharmaceutical Form: Granules for oral solution
Sponsors
Belgian Group of Digestive Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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 2 hypomagnesemia induced by EGFR targeted antibody therapy ;Secondary Objective: • To measure compliance to magnesium supplementation regimens • To measure the impact of magnesium supplementation on asthenia and Quality-of-Life ;Primary end point(s): After informed consent has been given, subjects meeting the inclusion criteria will be randomised to two different therapeutic approaches: • Arm A: No intervention (part 1), until appearance hypomagnesemia grade 1, followed by magnesium gluconate 3 g bid. orally (part 2) • Arm B: Prophylactic treatment with magnesium gluconate 3 g bid orally (part 1) until appearance of hypomagnesemia grade 1, followed by magnesium gluconate 3 g 6X/day orally (part 2) The primary efficacy variables of the part 1 of the study will be: • The slope of the change in serum magnesium levels since baseline • The mean number of bowel movements per day. The secondary efficacy variables of this part of the study will be: • The mean number of missed doses • The mean grade of fatigue according to CTC version 3.0 • The QoL score at two-weekly intervals recorded with the QLQ-C30 questionnaire from EORTC. • Patients will end part 1 of the study, as soon as the subjects have one serum magnesium level with grade 1 hypomagnesemia. They will then be entered in part 2. The primary efficacy variables of part 2 of the study will be: • The slope of the change in serum magnesium levels since appearance of grade 1 hypomagnesaemia • The mean number of bowel movements per day. The secondary efficacy variables of this part of the study will be: • The mean | — |
Countries
Belgium
Outcome results
None listed