Effects of Parenteral Nutrition in HSCT

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

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

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Drug: Glucose/Amino acids; Drug: Glucose/Amino acids/Lipids

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197022
    • Pavlov First Saint-Petersburg State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Glucose/Amino acids; Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight	Drug: Glucose/Amino acids; 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.; Other Names: 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
EXPERIMENTAL: 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	Drug: Glucose/Amino acids/Lipids; 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.; Other Names: 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; SMOFlipid 20% 100mL, 250mL, 500mL glass bottle; Nutriflex 70/180 lipid 625mL polyethylene 3-chamber bag; SMOFKabiven 1477mL polyethylene 3-chamber bag

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Petersburg State Pavlov Medical University
• Investigators: Study Director: Alexander Kulagin, Professor, Pavlov First Saint-Petersburg State Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ACTUAL): November 1, 2020
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: HSCT; Parenteral nutrition
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Pharmaceutical Solutions; Central Nervous System Stimulants; Sympathomimetics; Parenteral Nutrition Solutions; Adrenergic Uptake Inhibitors; Fat Emulsions, Intravenous; Methamphetamine; SMOFlipid
• Other Study ID Numbers: hsct/pn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No