Habibi Sajedeh, Ghoreishy Seyed Mojtaba, Imani Hossein, Barkhordar Maryam, Vaezi Mohammad, Sadeghi Erfan, Mohammadi Hamed
Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, P.O. Box 14155-6117, Tehran, Iran.
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
BMC Nutr. 2024 Jun 10;10(1):83. doi: 10.1186/s40795-024-00893-3.
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.
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®, 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.
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.
This clinical trial was registered in Iranian Registry of Clinical Trials ( http://www.irct.ir ) on 2022-12-09 with the code number IRCT20220208053971N2.
造血干细胞移植（HSCT）患者会出现多种副作用，尤其是那些影响营养摄入的副作用，可能导致体重减轻和营养不良。根据研究，口服营养补充剂（ONS）可能会增加他们的营养摄入并改善临床结果。本研究的目的是调查口服营养补充剂对自体造血干细胞移植患者营养和临床状况的影响。
通过网站www.randomization进行区组随机化后，38名患者将被纳入本研究，患者将以1:1的比例分配到干预组（ONS）或对照组。ONS组的患者将每天两次，在早餐和睡前零食时服用250毫升标准配方（安素，雅培营养），其中蛋白质含量为14 - 15%，持续21天。对照组除不接受ONS外，所有操作与ONS组相同。我们将检查的结果包括：体重、食欲、握力、小腿围、上臂围、总能量摄入、蛋白质摄入、碳水化合物摄入、脂肪摄入、口腔黏膜炎严重程度、住院期间感染率、移植失败、移植后复发率、中性粒细胞和血小板植入所需天数、移植后三个月内再次入院次数、移植后三个月内死亡率以及三天食物日记记录；所有评估将分三个阶段进行：移植前7天、移植后第14天和移植后第90天。
这些患者的体重减轻和营养不良是重大问题。在接受HSCT的患者中使用ONS尚未成为任何研究的主题。
本临床试验于2022年12月9日在伊朗临床试验注册中心（http://www.irct.ir）注册，注册号为IRCT20220208053971N2。
