Nutritional Status in Children Treated With Advanced Nutrition Therapy

NCT ID: NCT03049826

Last Updated: 2022-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Body Composition Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Stem cell transplantation (SCT)

Children undergoing stem cell transplantation (SCT)

Group Type EXPERIMENTAL

Nutritional status

Intervention Type OTHER

Body composition and nutrient status

Home parenteral nutrition (HPN)

Children receiving home parenteral nutrition

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy reference group

Healthy children

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutritional status

Body composition and nutrient status

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Christine Henriksen

Assossiate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Henriksen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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University of Oslo

Oslo, , Norway

Site Status

Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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AEV2017/1

Identifier Type: -

Identifier Source: org_study_id

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