Changes in body composition, dietary intake, and physical activity in children with cancer - a master protocol

Changes in body composition, dietary intake, and physical activity in children with cancer - a master protocol - FITco study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56855

Enrollment

500

Registered

2024-04-19

Start date

2025-07-04

Completion date

Unknown

Last updated

2026-03-16

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

Conditions

body composition, nutritional status, physical activity, exercise nutrition, physical activity

Interventions

not applicable&nbsp

Eligibility

Age

No minimum to 17 Years

Inclusion criteria

Inclusion criteria: - Between 0 and 18 years - Newly diagnosed with a haematological, solid, brain malignancy, or a  craniopharyngioma  - Being able to read and / or understand Dutch (either on of the parents or children) - Provided written informed consentFor sub-study A and C there are no additional inclusion criteria. For sub-study B, only patients diagnosed with ALL, bone sarcoma, or Hodgkin Lymphoma – or a healthy sibling of children diagnosed with ALL, bone sarcoma, or Hodgkin Lymphoma will be included.

Exclusion criteria

Exclusion criteria: - None

Design outcomes

Primary

Measure	Time frame
For the initial cohort: changes of body size (BMI, MUAC, waist and hip circumference), body composition (FM and FFM), dietary intake, and physical activity during and after treatment. Sub-study A: the relationship between changes in FM in the first three months after diagnosis and the presence of bacteraemia during the first year of treatment. Sub-study B: faecal microbiome (absolute numbers and diversity) in children with ALL, bone sarcoma, Hodgkin Lymphoma and healthy controls (siblings) Sub-study C: functional capacity as defined by age specific scales.	—

Measure

Time frame

For the initial cohort: changes of body size (BMI, MUAC, waist and hip circumference), body composition (FM and FFM), dietary intake, and physical activity during and after treatment. Sub-study A: the relationship between changes in FM in the first three months after diagnosis and the presence of bacteraemia during the first year of treatment. Sub-study B: faecal microbiome (absolute numbers and diversity) in children with ALL, bone sarcoma, Hodgkin Lymphoma and healthy controls (siblings) Sub-study C: functional capacity as defined by age specific scales.

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Secondary

Measure	Time frame
For the initial cohort, there are no secundary study parameters/outcomes of the study. Sub-study A: - The relationship between nutritional status at diagnosis (underweight, normal weight, overweight, obesity), but also changes in FFM, BMI, MUAC, waist- and hip circumference in the first three months after diagnosis and the presence of bacteraemie during treatment - The relationship between nutritional status at diagnosis (underweight, normal weight, overweight, obesity), but also changes in FM, FFM, BMI, MUAC, waist- and hip cicumference in the first three months after diagnosis and toxicity during treatment - The relationship between nutritional status at diagnosis (underweight, normal weight, overweight, obesity), but also changes in FM, FFM, BMI, MUAC, waist- and hip circumference, and survival outcomes (EFS and OS) - The relationship between nutritional status at diagnosis (underweight, normal weight, overweight, obesity), but also changes in FM, FFM, BMI, MUAC, waist- and hip circumference, and health-related quality of life-Changes in FM, FFM, BMI, MUAC, waist- and hip circumference over time, and risk factors associated (such as age, type of malignancy, treatment regime, dietary intake, and physical activity) For sub-study B and C, there are no secundary study parameters/outcomes of the study.	—

Measure

Time frame

For the initial cohort, there are no secundary study parameters/outcomes of the study. Sub-study A: - The relationship between nutritional status at diagnosis (underweight, normal weight, overweight, obesity), but also changes in FFM, BMI, MUAC, waist- and hip circumference in the first three months after diagnosis and the presence of bacteraemie during treatment - The relationship between nutritional status at diagnosis (underweight, normal weight, overweight, obesity), but also changes in FM, FFM, BMI, MUAC, waist- and hip cicumference in the first three months after diagnosis and toxicity during treatment - The relationship between nutritional status at diagnosis (underweight, normal weight, overweight, obesity), but also changes in FM, FFM, BMI, MUAC, waist- and hip circumference, and survival outcomes (EFS and OS) - The relationship between nutritional status at diagnosis (underweight, normal weight, overweight, obesity), but also changes in FM, FFM, BMI, MUAC, waist- and hip circumference, and health-related quality of life-Changes in FM, FFM, BMI, MUAC, waist- and hip circumference over time, and risk factors associated (such as age, type of malignancy, treatment regime, dietary intake, and physical activity) For sub-study B and C, there are no secundary study parameters/outcomes of the study.

—

Countries

Netherlands

Contacts

Public ContactW.J.E. Tissing

Prinses Máxima Centrum voor Kinderoncologie

W.J.E.Tissing@prinsesmaximacentrum.nl+31 88 97 272 72

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026