Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet-NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial.
Bottom Line: A polyamine-reduced diet (PRD) has recently demonstrated its efficacy to prevent OIPN in animals without adverse effects.The results will be disseminated in a peer-reviewed journal and presented at international congresses.NCT01775449.
Affiliation: Clermont Université, Clermont-Ferrand, France INSERM, U1107 NEURO-DOL, Clermont-Ferrand, France CHU Clermont-Ferrand, Clermont-Ferrand, France.Show MeSH
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Mentions: Depending on the chemotherapy course, the PRD will associate 2 to 4 cans/day of Polydol (Nutrialys Medical Nutrition, Saint-Grégoire, France; tables 1 and 2) and meals with low polyamine content18 (examples of PRD are presented in the tables 3–5). Polydol is a nutritional drink containing all the requisite nutrients but with low polyamine content (357 nmol/L of polyamines and 300 kcal per can of Polydol, data from Nutrialys Medical Nutrition). The number of cans of Polydol per day is adjusted as a function of the time course of the chemotherapy in order to optimise the patient's compliance with the diet while maximising the depletion of polyamine at the time of oxaliplatin administration (figure 1). Before the first chemotherapy cycle, patients will take 4 cans/day of Polydol for 7 days and 3 cans/day after the first chemotherapy infusion. For the other chemotherapy cycles, patients will take 3 cans/day of Polydol, 2 days before and 2 days after the chemotherapy infusions. Finally, between each chemotherapy infusion, the patients will receive 2 cans/day of Polydol (figure 1).
Affiliation: Clermont Université, Clermont-Ferrand, France INSERM, U1107 NEURO-DOL, Clermont-Ferrand, France CHU Clermont-Ferrand, Clermont-Ferrand, France.