Estudo duplo cego randomizado com suplementação com isolado de proteínas do soro para profilaxia da mucosite oral no transplante de células tronco hematopoéticas

Abstract

Patients conditioning regimen for stem cell transplantation hematopoietic have a high incidence of the more severe forms of oral mucositis. The whey protein isolate is composed of various cell growth factors, including beta transforming growth factors-β. Transforming growth factors-β compose a family of milk peptides and contributes to tissue repair. Based on the hypothesis that dietary supplementation with whey protein isolate has the potential to reduce the oral mucositis, we developed a randomized clinical study with patients undergoing autologous and allogeneic stem cell transplantation hematopoietic at the University Hospital of the Federal University of Juiz de Fora with different conditioning protocols. Patients were supplemented with a daily intake of whey protein isolate containing 50% of the daily protein requirements as Dietary Reference Intakes and classified later as supplement ingested amount of up median onset of oral mucositis. The National Cancer Institute criteria, version 4.0, were used to classify adverse events and to assess oral mucositis, based on the World Health Organization oral toxicity scale. A total of 40 patients undergoing hematopoietic stem cell transplantation were evaluated. Twenty were in the control group and 20 in the intervention group received whey protein concentrate. Oral mucositis (OM) had a mean duration of 7.52 days (SD: 2.73), ranging from 4 to 14 days. The mean onset ranged from the 2nd day before stem cell infusion to the 7th day after infusion and median on the 5th day after infusion. The incidence of OM in the intervention group was 40% and in the control group 65% (OR= 2.7857, CI= 2.3638 – 3.1962). Severe mucositis was present in 10% of the intervention group and 30% of the control group (OR= 3.8571, CI= 3.4409 – 4.2734). A smaller drop in plasma TGF-β was observed in the intervention group, the mean was 452.81ng/mL (SD: 391.25) at the beginning of neutropenia, while in the control group it was 172.90ng/mL (SD: 110.68) (p=0.022). Additional studies are needed to contribute to the current findings and to apply the possibilities of preventing this toxicity.