Effects of phosphoethanolamine associated or not to cisplatin chemotherapy on sperm parameters in adult rats

Abstract

The phosphoethanolamine, known as "cancer pill", have aroused interest in the scientific community because of the wide publicity and impact of press reports on the production and distribution of synthetic phosphoethanolamine in cancer treatment by São Carlos Chemistry Institute - University of São Paulo (USP), without the approval of the National Health Surveillance Agency (ANVISA). Even so, on April 13, 2016, the President Dilma Vana Rousseff signed Law No. 13269, authorizing the use of the substance by free choice of patients diagnosed with malignancy, as long as there is a medical report confirming the diagnosis and signing consent and responsibility for the patient or his legal representative. Although none toxicity sign or mutagenic effect of synthetic phosphoethanolamine has been detected inassay under the supervision of the Science, Technology and Innovation Department, the ANVISA indicate opposition to the release of the compound due to the usual dose is not determined. Beside, this drug was not being subjected to rigorous control criteria, and not provided the documentation required for registration synthetic and semi-synthetic drugs, to ensure the quality, safety and efficacy of these drugs according RDC No. 60 of October 10, 2014. Thus, considering: a) the absence of data on the effects treatment with phosphoethanolamine on reproduction; b) that the seminiferous epithelium is a tissue with high proliferative capacity and susceptible to the anti-proliferative and pro-apoptotic drug action; c) that phosphoethanolamine has pro-apoptotic effect and antiproliferative on tumor cells, d) that there is insufficient information on the action of this drugon proliferating normal tissues, this project aim to investigate whether phosphoethanolamine could cause spermatogenic damage, which may result in potentially quantitative and qualitative sperm changes with and without the combination with cisplatin chemotherapy.