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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29350
Enrollment
25
Registered
2013-07-31
Start date
2013-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child

Interventions

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, eac

Sponsors

University Medical Center Groningen (UMCG), Beatrix Children's Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
-Nutritional state (weight, length, mid upper arm circumference)

Secondary

MeasureTime frame
- 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)

Contacts

Public ContactW.J.E. Tissing

Posbus 30 001

+31 (0)50 3614213

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)