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Enteral versus parenteral feeding in pediatric oncology patients with gastro-intestinal mucositis


- candidate number15219
- NTR NumberNTR4099
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2013
- Secondary IDs2013/094  METc
- Public TitleEnteral versus parenteral feeding in pediatric oncology patients with gastro-intestinal mucositis
- Scientific TitleEnteral versus parenteral feeding in pediatric oncology patients with gastro-intestinal mucositis
- ACRONYMN/A
- hypothesisWhich 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.
- Healt Condition(s) or Problem(s) studiedChildren, Cancer, Mucositis, Nutrition
- Inclusion criteriaChildren(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.
- Exclusion criteria-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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2013
- planned closingdate1-aug-2016
- Target number of participants25
- InterventionsPatients 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.
- Primary outcome-Nutritional state (weight, length, mid upper arm circumference)
- Secondary outcome- The degree of mucositis measured by plasma citrulline
- Quality of life (using Pedsqual questionnaire every 5 days and daily Cantrills ladder and VAS score)
- Number of infectious complications
- Number of bacteraemias
- Percentage of calculated optimal quantity of tube feeding actually given
- Liver toxicity scores according to NCI-CTCAE version 4.0
- Length of hospital stay
- Clinical symptoms of mucositis (NCI-CTCAE 4.0)
- Timepoints- Nutritional state: before start of the chemotherapy course and before start of the next course
- Plasma citrulline: every 2 days until next chemotherapy course
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. W.J.E. Tissing
- CONTACT for SCIENTIFIC QUERIESDr. W.J.E. Tissing
- Sponsor/Initiator University Medical Center Groningen (UMCG), Beatrix Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD31-jul-2013 - 8-aug-2013


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