Fasting Intervention for children with Unilateral Renal Tumours to reduce Toxicity

Recruiting

Conditions: 10038365
Malignant Renal Tumor
Nephroblastoma
Renal tumor
10038364
10038430

Registration Number: NL-OMON54486

Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

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
- 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

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
- Opting for Nephron-Sparing Surgery (NSS)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: The incidence of Acute Kidney Injury (AKI) on post-operative<br /><br>day 3 (48-72 hours after end of anaesthesia)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: post-operative renal function, post-operative renal<br /><br>injury, side effects, adherence to fasting, change in fasting<br /><br>parameters/molecular markers, body weight, subject wellbeing, physical<br /><br>activity, anuria/oliguria, duration of post-operative hospital stay, admission<br /><br>to ICU, expression of cytoprotective/anti-oxidant genes</p><br>