Preventing Nerve Damage Induced by Chemotherapy

None listed

This clinical trial will use techniques and procedures that we have developed for measuring the plasma concentration of intact oxaliplatin and its motor nerve hyperexcitability to generate new information about the use of CaMg infusions for preventing oxaliplatin neurotoxicity. It will test the hypothesis that CaMg infusions alter the pharmacokinetics of oxaliplatin by increasing the rate of its conversion to reactive intermediates such as Pt(diaminocyclohexane)Cl2 by assessing the pharmacokinetics of intact oxaliplatin in colorectal cancer patients given the drug with and without CaMg infusions. In addition, it will test the hypothesis that CaMg infusions could prevent oxaliplatin neurotoxicity by suppressing its acute peripheral nerve hyperexcitability that will tested by needle electromyography (EMG) after oxaliplatin-based treatment given with and without CaMg infusions. The primary objective is to evaluate the effect of administration of CaMg infusions on the plasma pharmacokinetics of intact oxaliplatin in patients with colorectal cancer. The primary endpoint is intact oxaliplatin pharmacokinetic parameters, including AUC(0-t last), AUC(0-t infinity), Cmax, t1/2, Cl, Vd and Tss. The secondary objectives are to evaluate the effects of CaMg infusions on the pharmacokinetics of total platinum, motor nerve excitability and acute neurotoxicity symptoms in patients with colorectal cancer given oxaliplatin. Secondary endpoints are total platinum pharmacokinetic parameters (AUC(0-t last), AUC(0-t infinity), Cmax, t1/2, Cl, Vd and Tss), abnormal spontaneous high-frequency motor fibre action potentials and patient-reported neurotoxicity symptoms and study treatment preference post-treatment. Exploratory objectives include determining the feasibility of investigating neurotoxicity biomarkers, and changes in plasma concentration and urinary excretion of calcium, magnesium or oxalate, in colorectal cancer patients given oxaliplatin with or without CaMg infusions.