Zheng 2006.
| Methods | RCT Parallel design Single‐centre Children's Hospital, Shanghai Medical University, China | |
| Participants | 67 patients 1 to 12 years of age diagnosed with cancer in stages 1 to 3 AGE EN and FOS ‐ 7.5 ± 2.9 years EN alone ‐ 5.0 ± 3.1 years SEX EN and FOS ‐ 34% females EN alone ‐ 43% females DISEASE STATUS Neuroblastoma Wilms' tumour Malignant teratoma Hepatoblastoma Rhabdomyosarcoma Nutritional status not reported CHEMOTHERAPY/RADIOTHERAPY All patients received chemotherapy |
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| Interventions | 66 patients randomly assigned: EN and FOS ‐ n = 32, EN alone ‐ n = 34 EN ‐ consisted of 400 mL (1674 kJ) of a commercial enteral feed (Nutren Junior, Nestle, Konolfingen, Switzerland). No restriction in terms of dietary intake. FOS ‐ 2 g/L of FOS, Nestle, containing 70:30 Raftilose/Raftiline from Orafti (Brussels, Belgium). All products were delivered orally or with a nasogastric or gastrostomy tube on gravity administration. Both products contained proteins, carbohydrates, and fats with vitamins and minerals in amounts intended for full nutritional support of paediatric patients. |
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| Outcomes |
Primary outcomes Change in nutritional indices ‐ Change in weight‐for‐age (day 0 to 13; day 13 to 30; day 0 to 30) ‐ Change in height‐for‐age (day 0 to 13; day 13 to 30; day 0 to 30) ‐ Change in weight‐for‐height (day 0 to 13; day 13 to 30; day 0 to 30) ‐ Serum albumin ‐ Pre‐albumin Adverse events ‐ Stool culture positive for enterobacteria, bifidobacteria, lactobacillus, Clostridium (days 0, 3, 13, 30 stool samples analysed) ‐ Number of patients with nausea ‐ Number of patients with diarrhoea (stool frequency and consistency) Secondary outcomes "Feed tolerance" |
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| Notes | Patients received at least 400 mL of an assigned formula for 13 to 30 days | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: unclear how random assignment generated |
| Allocation concealment (selection bias) | Unclear risk | Comment: unclear how allocation assigned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: although states double blind, no further clarification |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: although states double blind, no further clarification |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: data from 66/67 participants were analysed |
| Selective reporting (reporting bias) | Low risk | Comment: blood pressure, heart rate, body temperature, respiratory rate recorded but not reported, but not related to outcomes in this review |
| Other bias | High risk | Comment: no copy of standardised questionnaire to record 24 hour dietary intake and feed tolerance measures included or cited in paper to assess quality/reproducibility |
BMT: bone marrow transplant CPN: central parenteral nutrition EN: enteral nutrition FOS: fructooligosaccharides FT: fluid replacement therapy GE‐TPN: glutamine enritched TPN HNR: high nutritional risk HSCT: hematopoietic stem cell transplant MAC: mid‐upper arm circumference NWTS: Mational Wilms' Tumor Study PN: parenteral nutrition PPN: peripheral parenteral nutrition RCT: randomised controlled trial RDA: recommended daily allowance S‐TPN: standard TPN TBI: total body irradiation TPN: total parenteral nutrition