Clinical trial NCT03049826: Nutritional Status in Children Treated With Advanced Nutrition Therapy
Official title: Nutritional Status in Children Treated With Advanced Nutrition Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Children
Keywords: nutrient
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2017-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: There are few studies about nutrition to children and adolescents with cancer, and in particular during stem cell transplantation (SCT). Studies from other countries suggest that malnutrition is common on admission; the situation decline during treatment and may persist for a long time.

Aim: This project aims to improve the nutritional therapy to children being treated for cancer and children undergoing stem cell transplantation

Detailed description: Design, methodology and selection: The study consist of two parts: A retrospective study (registry study) of malnutrition among all children with cancer, admitted during a two year period, and a clinical trial to evaluate the effect of a standardized nutrition protocol for children undergoing SCT. Nutritional status is assessed before, during and one year after treatment with SCT.

The subjects are 140 children and adolescents (2-17 years) being treated for cancer and a subgroup of 25 patients treated with SCT at Oslo University. The results will be compared with a reference group of 25 patients treated with home parenteral nutrition as well as 50 healthy reference persons in the same age group.

The methods used for measurement of nutritional status are: Body composition, bone density, blood tests, diet record, activity detection and measurement of quality of life. The measurements are done on three occasions for patients with cancer and stem cell transplantation, and on one occasion with a reference. Information on demographics and medical care will be taken from journal. Growth data will be collected from health centres when needed. Parents' experiences of children's feeding problems will also be examined.

Eligibility criteria: Inclusion Criteria:

* All patients will be recruited from Oslo University Hospital. Inclusion criteria are age 2 -17 years of age. The SCT and HPN group will include children who have not previously undergone transplantation, who do not have a pacemaker or other implants that prevent the measurement of muscle mass. Participants in the reference groups will be of the same age group, without congenital syndromes or previous cancers.

Exclusion Criteria:

* Exclusion criteria are patients who reject bone marrow

Primary outcomes:
measure: Body composition meassured with Lunar Dxa
timeFrame: After one year
Secondary outcomes:
measure: Blood vitamins and minerals
timeFrame: After one year
measure: Dietary intake
timeFrame: After one year
measure: Physical activity
timeFrame: After one year
measure: Health related Quality of life
timeFrame: After one year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Oslo
name: Christine Henriksen, PhD
role: PRINCIPAL_INVESTIGATOR
References: