Effects of Parenteral Nutrition in HSCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Parenteral Nutrition in Hematopoietic Stem Cell Transplantation: a Randomized Controlled Trial

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Drug: Glucose/Amino acids
* Drug: Glucose/Amino acids/Lipids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: - Secondary HSCT

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose/Amino acids<br>Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight | Drug: Glucose/Amino acids<br>* If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose and amino acids solutions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.<br>* Other names: Glucose 20% 500mL polyethylene bottle;|
| Experimental: Glucose/Amino acids/Lipids<br>Patients who will require nutritional support will receive parenteral nutrition consisting of glucose, amino acids and lipid emulsions according age and weight | Drug: Glucose/Amino acids/Lipids<br>* If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose, amino acids and lipid emulsions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.<br>* Other names: Glucose 20% 500mL polyethylene bottle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0 | Gastrointestinal toxicity symptoms (anorexia, vomiting, nausea, mucositis, diarrhea) before, during and after discontinuation of parenteral nutrition | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight in HSCT depending on nutritional support approach | Changes in body weight (kg) from baseline to day +30 | 30 days | 
| Changes in body mass index in HSCT depending on nutritional support approach | Changes in body mass index (kg/m^2) from baseline to day +30 | 30 days | 
| Changes in body composition in HSCT depending on nutritional support approach | 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 | 30 days | 
| Changes in resting energy expenditure in HSCT depending on nutritional support approach | Changes in resting energy expenditure (kcal) measured via bioimpedance from baseline to day +30 (device - Tanita bc-418 ma, Japan) | 30 days | 
| Severity and duration of anorexia, nausea, vomiting prevention | According CTCAE ver. 5.0, amount and duration of patient's oral food intake | 60 days | 
| Impact of parenteral nutrition on infection episodes after HSCT | 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. | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSCT, Parenteral nutrition