Which of 2 feeding strategies for children during chemotherapy induced mucositis is optimal for the patient: an elementary diet, containing only simple macronutrients administered via continuous enteral drip; or total parenteral nutrition.
ID
Bron
Verkorte titel
Aandoening
Child; Cancer; Mucositis; Nutrition
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
-Nutritional state (weight, length, mid upper arm circumference)
Achtergrond van het onderzoek
In this project we will test which of two feeding strategies for children during chemotherapy induced mucositis is optimal, an elementary diet administered via continuous enteral drip, or total parenteral nutrition. The study will compare the two feeding strategies in a randomized crossover design. Children admitted to the UMCG for treatment of AML of B-NHL will be included. Using a crossover design, during two identical chemotherapy courses, each patient will get both the elementary diet and the total parenteral nutrition randomly with the nutritional state as primary outcome.
Doel van het onderzoek
Which of 2 feeding strategies for children during chemotherapy induced mucositis is optimal for the patient: an elementary diet, containing only simple macronutrients administered via continuous enteral drip; or total parenteral nutrition.
Onderzoeksopzet
- Nutritional state: before start of the chemotherapy course and before start of the next course
- Plasma citrulline: every 2 days until next chemotherapy course
Onderzoeksproduct en/of interventie
Patients will be given standard nutrition(elementary diet administered via continuous enteral drip) or total parenteral nutrition during 2 identical chemotherapy courses. Using a crossover design, each patient will get both the standard diet and the study diet randomly.
Publiek
W.J.E. Tissing
Groningen 9700 RB
The Netherlands
+31 (0)50 3614213
Wetenschappelijk
W.J.E. Tissing
Groningen 9700 RB
The Netherlands
+31 (0)50 3614213
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Children(0-18 years of age) admitted to the University Medical Center Groningen for the treatment of acute myeloid leukemia(AML) or B-Non Hodgkin lymphoma(B-NHL). They receive chemotherapy according to the Dutch Childhood Oncology Group(DCOG), for both AML and B-NHL containing at least 2 identical chemotherapy courses.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-Patients and their parents are excluded when they are insufficiently capable of speaking and understanding the Dutch language.
-Patients are excluded when life expectancy is estimated to be below six months.
-No gastric tube in place in children who do eat during their chemotherapy (very rare) are excluded since we do not give a naso-gastric tube only for study purposes.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3937 |
| NTR-old | NTR4099 |
| Ander register | METc : 2013/094 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |