Effects of Parenteral Nutrition in HSCT
- Conditions
- Hematologic Malignancy
- Interventions
- Drug: Glucose/Amino acidsDrug: Glucose/Amino acids/Lipids
- Registration Number
- NCT04425642
- Lead Sponsor
- St. Petersburg State Pavlov Medical University
- Brief Summary
Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have undergone changes recently due to new conditioning regimen and graft versus disease prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition is increasing, the indications for parenteral nutrition are becoming more strict. The study aims to identify the role of parenteral nutrition in the context of rapidly changing supportive care approaches in HSCT
- Detailed Description
The study is interventional: in children and adolescents (2-17 years), adults with blood malignancy and inherited diseases who underwent autologous or allogeneic HSCT, nutritional status, parenteral nutrition tolerability and effectiveness will be assessed before and one month after HSCT. All patients who require parenteral nutrition will pass randomization via envelope technique - solutions containing glucose/amino acids or glucose/amino acids/lipid emulsions. The results will be compared with a control group which will not receive additional nutritional support. The methods used for measurement of nutritional status are: weight, body mass index, bioimpedance and hand grip strength (for adults only), blood tests, diet amount record.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Autologous HSCT
- Allogeneic HSCT
- Patients with indications for parenteral nutrition defined as unable to eat more than 50% of oral food intake due to posttransplant complications which leads to malnutrition and malabsorption
- Signed informed consent
- Age > 2 years
- Secondary HSCT
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glucose/Amino acids Glucose/Amino acids Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight Glucose/Amino acids/Lipids Glucose/Amino acids/Lipids Patients who will require nutritional support will receive parenteral nutrition consisting of glucose, amino acids and lipid emulsions according age and weight
- Primary Outcome Measures
Name Time Method Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0 60 days Gastrointestinal toxicity symptoms (anorexia, vomiting, nausea, mucositis, diarrhea) before, during and after discontinuation of parenteral nutrition
- Secondary Outcome Measures
Name Time Method Changes in resting energy expenditure in HSCT depending on nutritional support approach 30 days Changes in resting energy expenditure (kcal) measured via bioimpedance from baseline to day +30 (device - Tanita bc-418 ma, Japan)
Changes in body mass index in HSCT depending on nutritional support approach 30 days Changes in body mass index (kg/m\^2) from baseline to day +30
Impact of parenteral nutrition on infection episodes after HSCT 60 days To compare the incidence of sepsis between patients with and without parenteral nutrition. The sepsis criterions are: laboratory tests - positive blood culture, enchanced serum level of C-reactive protein (mg/L) and procalcitonin (mcg/L); clinical signs - fever.
Severity and duration of anorexia, nausea, vomiting prevention 60 days According CTCAE ver. 5.0, amount and duration of patient's oral food intake
Changes in body weight in HSCT depending on nutritional support approach 30 days Changes in body weight (kg) from baseline to day +30
Changes in body composition in HSCT depending on nutritional support approach 30 days Changes in body composition via bioimpedance by Tanita bc-418 ma, Japan (total body water (kg), muscle mass (kg), fat (kg)) from baseline to day +30
Trial Locations
- Locations (1)
Pavlov First Saint-Petersburg State Medical University
🇷🇺Saint Petersburg, Russian Federation