Clinical trial NCT04425642: Effects of Parenteral Nutrition in HSCT
Official title: Effects of Parenteral Nutrition in Hematopoietic Stem Cell Transplantation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Keywords: HSCT
Parenteral nutrition
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0
timeFrame: 60 days
Secondary outcomes:
measure: Changes in body weight in HSCT depending on nutritional support approach
timeFrame: 30 days
measure: Changes in body mass index in HSCT depending on nutritional support approach
timeFrame: 30 days
measure: Changes in body composition in HSCT depending on nutritional support approach
timeFrame: 30 days
measure: Changes in resting energy expenditure in HSCT depending on nutritional support approach
timeFrame: 30 days
measure: Severity and duration of anorexia, nausea, vomiting prevention
timeFrame: 60 days
measure: Impact of parenteral nutrition on infection episodes after HSCT
timeFrame: 60 days
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint-Petersburg State Medical University
Study officials:
affiliation: Pavlov First Saint Petersburg State Medical University
name: Alexander Kulagin, Professor
role: STUDY_DIRECTOR
References: