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NCT Number: NCT04425642

Effects of Parenteral Nutrition in HSCT

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

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Key information

Conditions

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

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pavlov First Saint-Petersburg State Medical University

Saint Petersburg, 197022, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

Other names: 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

Primary outcomes

  1. Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0

    Time frame: 60 days

    Gastrointestinal toxicity symptoms (anorexia, vomiting, nausea, mucositis, diarrhea) before, during and after discontinuation of parenteral nutrition

Secondary outcomes

  1. Changes in body weight in HSCT depending on nutritional support approach

    Time frame: 30 days

    Changes in body weight (kg) from baseline to day +30

  2. Changes in body mass index in HSCT depending on nutritional support approach

    Time frame: 30 days

    Changes in body mass index (kg/m^2) from baseline to day +30

  3. Changes in body composition in HSCT depending on nutritional support approach

    Time frame: 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

  4. Changes in resting energy expenditure in HSCT depending on nutritional support approach

    Time frame: 30 days

    Changes in resting energy expenditure (kcal) measured via bioimpedance from baseline to day +30 (device - Tanita bc-418 ma, Japan)

  5. Severity and duration of anorexia, nausea, vomiting prevention

    Time frame: 60 days

    According CTCAE ver. 5.0, amount and duration of patient's oral food intake

  6. Impact of parenteral nutrition on infection episodes after HSCT

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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