The effect of oral nutrition supplement (ONS) on the nutritional and clinical status of patients undergoing autologous hematopoietic stem cell transplantation: study protocol for a randomized controlled clinical trial

Introduction Several side effects within the patients undergoing hematopoietic stem cell transplantation (HSCT), especially ones that influence nutrition intake, can cause weight loss and malnutrition. Based on studies, oral nutritional supplement (ONS) may reinforce their nutrient intake and progress clinical outcomes. The objective of this research is to investigate the effect of oral nutrition supplements on the nutritional and clinical status of patients undergoing autologous hematopoietic stem cell transplantation.Methods After block randomization used the website www.randomization, 38 patients will be enrolled in this study, patients will be allocated to the intervention (ONS) or control groups in a 1: 1 ratio. Patients in the ONS group will receive 250 ml of standard formula (Ensure (R), Abbott Nutrition) which has 14-15% protein twice a day, in the morning and bedtime snacks for 21 days. All the procedures done in the control group will be the same as the ONS group except receiving ONS. We will examine the outcomes include; weight, appetite, hand grip strength, calf circumference, mid-arm circumference, total energy intake, protein intake, carbohydrate intake, fat intake, severity of oral mucositis, rate of infection during hospitalization, graft failure, recurrence rate after transplantation, the number of days it takes for neutrophil and platelet engraftment to occur, number of readmissions after transplantation during three months, mortality rate up to three months after transplantation and the three-day food diary record; all the evaluations will be carried out in three steps; 7 days before transplant, on the 14th day after transplantation, and on the 90th day after the transplantation.Discussion These patients' weight loss and malnourishment are significant concerns. The use of ONS in patients receiving HSCT has not been the subject of any research.Trial registration This clinical trial was registered in Iranian Registry of Clinical Trials (http://www.irct.ir) on 2022-12-09 with the code number IRCT20220208053971N2. Limitations 1. Problems related to the possibility of non-cooperation of the hospital and patients. 2. Limitations on available ONS choices and costs.Limitations 1. Problems related to the possibility of non-cooperation of the hospital and patients. 2. Limitations on available ONS choices and costs.Strengths 1. The strength of this protocol is the RCT design, as the field of nutrition is limited by a lack of RCTs. 2. Our study is the first RCT on ONS in patients receiving a HSCT.Strengths 1. The strength of this protocol is the RCT design, as the field of nutrition is limited by a lack of RCTs. 2. Our study is the first RCT on ONS in patients receiving a HSCT.