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. 2017 May 19;2017(5):CD011598. doi: 10.1002/14651858.CD011598.pub2

Samuels 1981.

Methods Randomised clinical trial, USA
Participants 35 hospitalised adults admitted for stage III metastatic testicular cancer, at nutritional risk due to anthropometrics
Male:Female = Not reported
Mean age = Not reported
Exclusion criteria: Participants characterised as severely malnourished (weight loss > 12%, duration not stated)
Interventions Experimental group: received intravenous hyperalimentation solution containing 25% dextrose with 4.25% amino acids, supplementary vitamins, electrolytes and trace elements, which provided 35 kcals/kg/day. Intervention started on day 1 of hospitalisation, and was continued throughout the course of the chemotherapy, terminating 24 hrs before discharge.
The mean duration of IVH was 48 days for noninfected participants and 18 days for infected participants. (n = 20)
 Control group: control participants who developed significant gastro‐intestinal toxic effects received 3 litres of parenteral fluids daily, usually containing 5% glucose, 0.5 normal saline and 40 mEq of potassium chloride. In the event of > 12% weight loss after chemotherapy, control participants were crossed over to receive intravenous hyperalimentation at the discretion of the investigator. (n = 15)
Co‐intervention: Both groups was divided in 2, where 1 group received vinblastine and bleomycin, and the other received vinblastine, bleomycin and cisplatin.
Outcomes Mortality, weight, septicaemia, pneumonia, infections, liver function, leukopenia, serum albumin, serum transferrin, granulocyte count, granulocytopenic fever, platelet count and oral toxicity
Study dates Not stated
Notes We could obtain no contact information from the authors. The 35 patients were stratified into 3 nutritional‐status categories: well‐nourished, moderately malnourished and malnourished.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The trial was block‐randomised using random‐number tables.
Allocation concealment (selection bias) Unclear risk Allocation concealment was done using sealed envelopes but it was unclear if they were opaque.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not described
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There were no dropouts.
Selective reporting (reporting bias) Low risk No protocol could be obtained , but all‐cause‐mortality and serious adverse events were reported.
For‐profit bias Low risk Supported by contracts from the division of Cancer Cause and prevention, National Cancer institute, National Institutes of Health, Department of Health and Human Services.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.