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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.
Habibi, Sajedeh; Ghoreishy, Seyed Mojtaba; Imani, Hossein; Barkhordar, Maryam; Vaezi, Mohammad; Sadeghi, Erfan; Mohammadi, Hamed.
Affiliation
  • Habibi S; Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, P.O. Box 14155-6117, Tehran, Iran.
  • Ghoreishy SM; Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
  • Imani H; Student research committee, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
  • Barkhordar M; Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, P.O. Box 14155-6117, Tehran, Iran.
  • Vaezi M; Cell Therapy and Hematopoietic Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Sadeghi E; Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran.
  • Mohammadi H; Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran.
BMC Nutr ; 10(1): 83, 2024 Jun 10.
Article in En | MEDLINE | ID: mdl-38858716
ABSTRACT

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®, 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.
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: BMC Nutr Year: 2024 Document type: Article Affiliation country: Iran

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: BMC Nutr Year: 2024 Document type: Article Affiliation country: Iran