The effect of oral nutrition supplement (ONS) on nutritional and clinical status of patients undergoing autologous hematopoietic stem cell transplantation

Determining the effect of oral nutritional supplements on the nutritional and clinical status of patients undergoing autologous bone marrow transplantation

The study is a randomized clinical trial, with a control group, phase 2 on 38 patients. The type of intervention in the treatment group is an oral nutritional supplement. The intervention will be for 21 days and the follow-up will be up to 90 days after the transplant. The control group will not receive any supplements.

The treatment group will receive an oral nutritional supplement containing 500 kcal of energy and 14-15% protein. The study will be conducted in Shariati Hospital. 250 cc of formula will be given to patients in the morning snack and before bedtime. The control group will not receive any supplements. The intervention lasts for 21 days and we will follow up with the patients until 90 days after the transplant. Blinding will not be done.

Patients with lymphoma or multiple myeloma are candidates for autologous bone marrow transplantation /Reluctance to cooperate

The intervention in the treatment group will be an oral nutritional supplement of 500 kcal containing 14-15% protein. The formula will be given to patients in the amount of 250 ccs in the morning and before going to bed. The control group will not receive any supplements. The intervention will be carried out for 21 days and we will follow up with the patients until 90 days after the transplant.

Weight, appetite, hand grip strength, calf circumference, mid-arm circumference, malnutrition based on PG-SGA tool, oral mucositis, infection during hospitalization, graft failure, relapse after transplantation, number of days to platelet transplantation and neutrophils, readmission within 90 days post-transplant, and mortality up to 90 days post-transplant.

Stratified block randomization will be performed based on the sex and age and using the site www.randomization.com. In this method, each group will be assigned one of the letters A and B, and randomization will be done in blocks with size of 4 . This will be done for sex (male and female) and age (18-35 and 35-50 years old). Within each class, patients will be randomly assigned to one of the two study groups in a 1: 1 ratio. The randomization process will be performed by someone outside the research team.

Due to the confidentiality of participant information, it is not possible to publish it.