Effects of Parenteral Nutrition in HSCT

NCT04425642 | Completed

• 1 other identifier: hsct/pn
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Hematologic Malignancy

Keywords

HSCT; Parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in body weight in HSCT depending on nutritional support approach

  30 days

• Changes in body mass index in HSCT depending on nutritional support approach

  30 days

• Changes in body composition in HSCT depending on nutritional support approach

  30 days

• Changes in resting energy expenditure in HSCT depending on nutritional support approach

  30 days

• Severity and duration of anorexia, nausea, vomiting prevention

  60 days

Study Arms (2)

Glucose/Amino acids

EXPERIMENTAL

Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight

Drug: Glucose/Amino acids

Glucose/Amino acids/Lipids

EXPERIMENTAL

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

Interventions

Glucose/Amino acids DRUG

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.

Also known as: Aminoplasmal E 15% 500mL glass bottle, Aminoplasmal E 10% 500mL glass bottle, Aminoven infant 10% 100mL glass bottle, Nutriflex 48/150 1000mL polyethylene 2-chamber bag, Nutriflex 70/240 1500mL polyethylene 2-chamber bag, Glucose 20% 500mL polyethylene bottle

Glucose/Amino acids

Glucose/Amino acids/Lipids DRUG

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.

Also known as: Aminoplasmal E 15% 500mL glass bottle, SMOFlipid 20% 100mL, 250mL, 500mL glass bottle, Nutriflex 70/180 lipid 625mL polyethylene 3-chamber bag, Aminoplasmal E 10% 500mL glass bottle, Aminoven infant 10% 100mL glass bottle, Nutriflex 48/150 1000mL polyethylene 2-chamber bag, Nutriflex 70/240 1500mL polyethylene 2-chamber bag, SMOFKabiven 1477mL polyethylene 3-chamber bag, Glucose 20% 500mL polyethylene bottle

Glucose/Amino acids/Lipids

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Secondary HSCT

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

Pavlov First Saint-Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Hyperphagia

Interventions

Glucose; Amino Acids; SMOFlipid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Amino Acids, Peptides, and Proteins

Study Officials

• Alexander Kulagin, Professor

  Pavlov First Saint Petersburg State Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for research, Raisa Gorbacheva Memorial Research Institute for Pediatric Oncology, Hematology and Transplantation

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 11, 2020
• Study Start: February 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: June 1, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)