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Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

ABSTRACT: RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity. PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.

DISEASE(S): Neurotoxicity,Chemotherapeutic Agent Toxicity,Colorectal Cancer,Neurotoxicity Syndromes,Neuropathy

PROVIDER: 2087278 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Primary objectives: • 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 Primary endpoints: 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 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. •

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Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

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