Malignant Renal Tumor Nephroblastoma Renal tumor
Conditions
Interventions
Nutritional preconditioning by fasting for 10, 14 or 18 hours.
Age Group 1: 6-24 Months (0,5 to 2 years): 10 hours of fasting
Age Group 2: 25-84 Months (2 to 7 years): 14 hours of fasting
Age Group 3
Sponsors
Prinses Máxima Centrum voor Kinderoncologie
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Children and young adolescents within the age range of 6 months up and until 19 years are eligible for this study. In order to further be eligible to participate in this study, a subject must meet all of the following criteria: - Written consent of parent(s)/caregiver(s)/legal representative - Subject written consent when older than 12 years - Unilateral localized renal tumours, not metachronous - Planned radical tumour-nephrectomy or nephron sparing surgery in a localized unilateral renal tumor. - Adequate understanding and/or mastery of the Dutch language Since biopsy and therefore histological diagnosis of the type of renal tumour is not acquired pre-operatively, there needs to be a strong clinical suspicion or diagnosis of a renal tumour, opting for surgical excision after pre-operative chemotherapy (treatment planned according to SIOP-RTSG-UMBRELLA).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Bilateral renal involvement - Anorexia / very low body weight o Subjects younger than 1 year: SD-score < -2 for weight by age o Subject older than 1 year: SD-score < -2 for weight by height - Underlying metabolic disease prohibiting a period of fasting - Metastatic disease - Unilateral local, metachronous disease - Diabetes Mellitus Type 1 or 2 - No curative treatment possible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The incidence of Acute Kidney Injury (AKI) on post-operative day 3 (48-72 hours after end of anaesthesia) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: post-operative renal function, post-operative renal injury, side effects, adherence to fasting, change in fasting parameters/molecular markers, body weight, subject wellbeing, physical activity, anuria/oliguria, duration of post-operative hospital stay, admission to ICU, expression of cytoprotective/anti-oxidant genes | — |
Countries
Netherlands
Contacts
Public ContactM. M. Heuvel-Eibrink
Prinses Máxima Centrum voor Kinderoncologie
Outcome results
None listed