Valdivieso 1987.
Methods | Randomised clinical trial, USA | |
Participants | 65 hospitalised adults, previously untreated, with small cell bronchogenic carcinoma admitted for chemotherapy, at nutritional risk according to the trialist Male:Female = 40:18 Mean age = 59 years |
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Interventions | Experimental group: Intravenous hyperalimentation 500 ml 50% glucose, 500 ml 8.5% amino acid(n = 30)
Control group: No intervention (n = 35) Co‐intervention: oral nutrition as wanted + chemotherapy |
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Outcomes | Myelosuppresive toxicity, infectious complications, weight, triceps skinfold, mid‐upper arm muscle circumference, days of hospitalisation, survival, remission | |
Study dates | Not stated | |
Notes | The same participants were randomised to prophylactic antibiotics or no prophylactic antibiotics. The 2 groups of antibiotics could be described as being similar in the 2 groups. We contacted the authors on 23rd June 2015 by email: manuelva@umich.edu. The author replied that he had left the research environment and could not provide further information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
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 | Unclear risk | There were above 5% dropouts, and the trial did not use proper methodology to deal with those lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | The trial reported mortality and serious adverse events. |
For‐profit bias | Low risk | The trial was funded by a non‐profit organisation (National Cancer Institute). |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |