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

Suspended
Conditions
Child
Cancer
Mucositis
Nutrition
Registration Number
NL-OMON29350
Lead Sponsor
niversity Medical Center Groningen (UMCG), Beatrix Children's Hospital
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

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.

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
-Nutritional state (weight, length, mid upper arm circumference)
Secondary Outcome Measures
NameTimeMethod
- The degree of mucositis measured by plasma citrulline<br /><br>- Quality of life (using Pedsqual questionnaire every 5 days and daily Cantrills ladder and VAS score)<br /><br>- Number of infectious complications<br /><br>- Number of bacteraemias<br /><br>- Percentage of calculated optimal quantity of tube feeding actually given<br /><br>- Liver toxicity scores according to NCI-CTCAE version 4.0<br /><br>- Length of hospital stay<br /><br>- Clinical symptoms of mucositis (NCI-CTCAE 4.0)
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