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

Nixon 1981.

Methods Randomised clinical trial, USA
Participants 50 hospitalised adults with advanced colorectal carcinoma, at nutritional risk according to the trialist
Male:Female = 19:26 (gender not reported for five participants)
Mean age = 58 years
Exclusion criteria: severe heart or renal disease, antibiotic‐resistant infections, weight loss > 24% of premorbid level, or important nutrient losses from vomiting, diarrhoea, or fistulae. No surgery, radiation, or chemotherapy could have occurred for 2 weeks prior to study entry.
Interventions Experimental group: Total parenteral nutrition and chemotherapy. Participants were to receive 28 days of central parenteral hyperalimentation at the level of 30 ‐ 35 kcal and 0.2 ‐ 0.3 N/kg body weight/day. Chemotherapy (5‐fluorouracil + methyl CCNU) was begun on the 14th day after these nutrient levels were reached. Only 1 course of total parenteral nutrition was administered; afterwards total oral intake as wished was tolerated.(n = 25)
Control group: No intervention. Control group were begun immediately on an identical chemotherapy regimen and allowed to eat as they wished. (n = 25)
Co‐intervention: Chemotherapy
Outcomes Overall median survival (days)
Study dates Not stated
Notes We found no contact information for the authors.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Low risk The trial used a sealed‐envelope system developed by the support contractor.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding was not performed.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 5 (10%) of the participants were withdrawn from the trial and the analyses. It was unclear how the trial dealt with missing data.
Selective reporting (reporting bias) High risk No protocol could be obtained and the trial did not report on all‐cause mortality or serious adverse events.
For‐profit bias Low risk The study was funded by NIH contract NO1‐CP‐65892, NIH Grants RR39 and 16255, the American Legion Gioia Osborne Cancer Research Fund, and the state of Georgia Contract Cancer‐Nutrition.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.