Fasting Intervention for children with Unilateral Renal Tumours to reduce Toxicity

Rationale:
Childhood renal tumours account for around 7% of all childhood cancers. Most of these cases are Wilms tumour, around 90%. The annual incidence of renal tumours is seven cases per million children younger than 15 years. In the Netherlands, the SIOP-RTSG approach is considered standard of clinical care, it consists of preoperative chemotherapy and surgical excision. Postoperative chemo- and radiation therapy is advised on a risk-based approach. For Wilms tumours, the use of these regimens has resulted in excellent survival rates, the overall five-year survival rates are approaching 90 percent. Efforts to decrease toxicity are now being pursued.

Caloric restriction (CR), meaning reduced intake of food without malnutrition, is associated with extended life span, lower risk of age associated diseases, increased resistance against side-effects of chemotherapy, improved fitness and increased resistance to acute stress. Nutritional preconditioning, by long-term CR or short-term fasting, represents a non-invasive, non-expensive method of mitigating the effects of acute surgery-induced stress. It increases expression of cytoprotective genes, immunomodulation via increased anti-inflammatory cytokine production and decreases the expression of pro-inflammatory markers. As surgery is an important part of renal tumour treatment, preoperative fasting could be introduced to further improve outcomes. Since renal tumour patients undergo a well-defined therapeutic regimen in which chemotherapy and surgery do not overlap, this leaves a well-defined preoperative time window required to perform preoperative fasting.

Objective: to investigate the effect of a preoperative fasting diet on postoperative renal function recovery after renal tumour surgery.

Study design: a single-centre, prospective, randomized, non-blinded, intervention study

Study population: children between 6 months and 18 years of age, diagnosed with a unilateral renal tumour, opting for curative treatment including preoperative chemotherapy and subsequent surgical excision of the renal tumour.

Intervention: nutritional preconditioning by preoperative fasting for 10, 14 or 18 hours.

Main study parameters/endpoints: the incidence of Acute Kidney Injury (AKI) on postoperative day 3.

We aim to investigate the effect of a preoperative fasting diet on postoperative renal function recovery after renal tumour surgery.

2 and 1 weeks before surgery, 1 day before surgery, and 1-5 days after surgery, 2 and 4 weeks after surgery

Preoperative fasting for 10, 14 or 18 hours, intervention duration depends on subject age