Wei 2013.
Methods | Randomised clinical trial, China | |
Participants | 79 hospitalised adults admitted for the 1st time with gastro‐intestinal cancer and distant metastasis undergoing Capecitabine monotherapy regimen for 2 cycles. They were younger than 60, KPS score > 60; had normal liver and kidney function, ECG, without chemotherapy contraindication, at nutritional risk due to trialist indication Male:Female = 42:37 Mean age = unknown Exclusion criteria: none stated |
|
Interventions | Experimental group: Parenteral and enteral nutrition. The participants were given parenteral nutrition support according to gastro‐intestinal function. If the oral intake was less than 60% of normal intake, a 30% fat emulsion injection was used (Intralipid force in Huarui Pharmaceutical Co. Ltd), as well as amino acid injection (Novamin, SSPC), fat‐soluble vitamins (Zhi Weibao, North China Pharmaceutical Limited by Share Ltd), water‐soluble vitamins (Soluvit, Huarui Pharmaceutical Co. Ltd), insulin, potassium chloride and sodium chloride to give parenteral nutrition for 3 14 days. The amount of enteral nutrition was increased gradually according to gastro‐intestinal tolerability, and reaching complete enteral nutrition when nausea, vomiting and diarrhoea were absent and the body state allowed for it. The enteral nutrition was given as an emulsion (Supportan, Huarui Pharmaceutical Co. Ltd.), with an initial dosage of 20% to 50% of the required nutrients. The calorie level was 80 kJ/(kg/day), protein was 1 g/(kg/day), and the ratio of non‐protein calorie versus nitrogen was 100:1. The treatment lasted for 2 cycles of chemotherapy. (n = 42) Control group: no intervention (n = 37) Co‐interventions: chemotherapy |
|
Outcomes | Nutritional statusKPS, toxic reaction and nosocomial infection rate | |
Study dates | Not stated | |
Notes | We contacted the authors on 21st January 2016 by phone. We received information on allocation sequence generation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random‐number table |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of participants with incomplete data was not reported. |
Selective reporting (reporting bias) | Unclear 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 trial was funded by Special funds of the central government (2012QN050). |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |