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. |
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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 |
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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Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 5 (10%) of the participants were withdrawn from the trial and the analyses.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. |