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

Clamon 1985.

Methods Randomised clinical trial, USA
(Prior to randomisation, participants were stratified by extent of disease, weight loss over or under 2% during the 3 months prior to diagnosis, and performance score)
Participants 119 hospitalised adults that had histologically‐ or cytologically‐documented small cell lung cancer, with no previous therapy, measurable or evaluable disease, a life expectancy of more than 8 weeks, and a performance score of 3 or better on the ECOG scale, at nutritional risk, due to trialist indication
Male:Female = 89:30
Mean age = 60 years
Exclusion criteria: Leukocyte count less than 3000/mm3, platelet count < 100.000/mm3, bilirubin level more than 2 mg/dl, creatinine more than 2 mg/dl or blood urea nitrogen (BUN) level greater than 30 mg/dl, recent myocardial infarction, congestive heart failure or arrhythmia precluding adriamycin (doxorubicin) therapy, documented central nervous system metastases, superior vena cava obstruction, inappropriate antidiuretic hormone secretion, or significant other medical problems precluding central venous hyperalimentation
Interventions Experimental group: Central IVH for 28 days if no complications occurred.
IVH was provided using an amino acid mixture (Travasol, Travenol Company, Deerfield, IL), glucose, and 10% lipid emulsion. Nonprotein calories were evenly divided between glucose and lipid. Electrolytes, multi‐vitamins, and trace elements were added daily; folate and vitamin K were given weekly. Vitamin B12 was given monthly.
Participants nutritionally normal at entry to the study were started at 32 cal/kg/day and 1 g protein/kg/day. After 1 week, they were increased to 40 cal/kg and 1.25 g of protein/kg a day and maintained at this level for 3 weeks. Participants nutritionally depleted at entry into the study were started at 48 cal/kg and 1.5 g of protein/kg/day and increased to 56 cal/kg and 1.75 g/kg of protein a day. The IVH was started 1 week prior to the 1st dose of chemotherapy. Participants at the University of Toronto were maintained without oral intake while receiving IVH; at all other institutions participants were allowed to eat ad libitum during IVH. (n = 57)
Control group: No intervention (n = 62)
Outcomes A nutritional assessment consisting of weight, serum albumin, total iron binding capacity, midarm muscle circumference, triceps skinfold thickness, and creatinine height index was obtained at the beginning of the study (baseline) and repeated every 3 weeks.
3‐day diet records were obtained before the initiation of treatment and at the end of 3 weeks after the 1st, 2nd, 4th, 8th, and 12th cycles of chemotherapy and at the end of 1 year.
Study dates Not stated
Notes We contacted the authors on 5th October 2015 by email: emmoran@uci.edu; edgar.moran@va.gov. We received no reply.
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 The number of participants with incomplete data was not reported.
Selective reporting (reporting bias) High risk No protocol could be obtained and the trial did not report all‐cause mortality or serious adverse events.
For‐profit bias Low risk This trial was sponsored and funded by the Diet, Nutrition and Cancer Program of the National Cancer Institute.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.