Randomized double blind placebo controlled study of oral lithium for prevention of chemotherapy induce peripheral neuropathy in breast cancer patients under treatment by Taxans and Platinium base medicines

Determination of lithium effectiveness in prevention of peripheral neuropathy in breast cancer patients under treatment with Taxans and Platinium base medicines

Clinical trial, placebo control, parallel group, double blind, randomized

Place of study: Field of study: clinical, randomized, double_blind, placebo control Method of study: Between breast cancer patients, we will choose people with inclusion criteria. They will be divided into 2 groups of medicine and placebo by randomization. First group will receive oral 300 mg lithium one day before every chemotherapy cycle up to 5 days later and second group will receive placebo one day before every chemotherapy cycle up to 5 days later. From all patients in this study, we will take EMG_NCV and scoring of peripheral neuropathy, before starting the first chemotherapy cycle, 3 months later, 6 months later and 1 year later. Blinding: In this study, patients and main researcher have blinded and they don't have information that each patient in which group has settled.

Inclusion criteria : Breast cancer women between 18 to 60 years old Exclusion criteria : Dissatisfaction of patients to participate in study Pregnant and breastfeeding women and also women with intention of pregnancy Patients with peripheral nerves disorders, renal, thyroid, and cardiovascular disorders, diabetes, bipolar

Intervention group : People in this group will receive 300 mg oral lithium daily, one day before every chemotherapy cycle up to 5 days later Control group : People in this group will receive placebo daily, one day before every chemotherapy cycle up to 5 days later

Breast cancer, chemotherapy, prevention, peripheral neuropathy, lithium, EMG_NCV , scoring of peripheral neuropathy

In this study by using specialized randomization method and daily references list, patients with inclusion criteria, by chance and in quadruple blocs, divided into 2 groups: A and B Patients with "A" CARD will enter into intervention group (chemotherapy + lithium) and patients with "B" CARD will enter into control group (chemotherapy + placebo).

In this double_blind investigation, participating patients and main researchers have remained blinded and they don't have information toward setting patients in intervention group or control group.