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Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery

ABSTRACT: RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy. PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage IV colorectal cancer that has been completely removed by surgery.

DISEASE(S): Neurotoxicity,Neurotoxicity Syndromes,Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2028254 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: IMPACT Advanced Recovery is a beverage made by Nestle which contains special nutrients (immunonutrients) which may enhance the immune system in patients having major surgery, improving patient recovery. In our treatment group, patients undergoing surgery for colorectal (bowel) cancer will be given a pamphlet containing information on healthy eating for surgery, as well as IMPACT Advanced Recovery drinks to consume before the operation. These participants will be instructed to take 3 x 237 mL drink packs a day, for 5 consecutive days before their operation, with the last drink to be taken two days before their operation. The ingredients in IMPACT Advanced Recovery (Vanilla) are: Water, Sugar, Calcium caseinate (milk), Sodium caseinate, L-arginine, Refined fish oil (anchovy, sardine) and less than 2% of corn oil, Citric acid, Medium chain triglycerides, Maltodextrin, Natural and artificial flavor, Yeast extract, Potassium citrate, Potassium chloride, Calcium phosphate, Magnesium phosphate, Salt, Magnesium chloride, Cellulose gel, Cellulose gum, Choline chloride, Sodium ascorbate, Sucralose (sweetener), Carrageenan, Zinc sulfate, Ferrous sulfate, D-alpha-tocopherol, Niacinamide, Soybean oil, Dl-alpha tocopheryl acetate, Calcium pantothenate, Copper gluconate, Manganese sulfate, Vitamin A palmitate, Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, Beta-carotene, Folic acid, Potassium iodide, Sodium selenite, Sodium molybdate, Chromium chloride, Vitamin K1, Biotin, Vitamin D3, Vitamin B12. The pamphlet for the treatment group provides the same information as the control pamphlet, as well as information on what IMPACT Advanced Recovery is, its ingredients and reported benefits, and how to take it before one’s operation. These pamphlets have been ma Primary outcome(s): Number of infectious complications will be calculated by reviewing medical records, and classified using the Centers for Disease Control and Prevention classification: superficial incisional, deep incisional or organ/space infection.[30 days post-operatively] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

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 Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery

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