scholarly journals Comment on ‘Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102)’

2013 ◽  
Vol 109 (9) ◽  
pp. 2505-2505 ◽  
Author(s):  
H Nagano
Keyword(s):  
Cervical Cancer ◽  
Randomised Controlled Trial ◽  
Neoadjuvant Chemotherapy ◽  
Radical Surgery ◽  
Controlled Trial ◽  
Phase Iii ◽  
Oncology Group ◽  
Japan Clinical Oncology Group ◽  
Randomised Controlled ◽  
Group Trial

scholarly journals Children’s Oxygen Administration Strategies And Nutrition Trial (COAST-Nutrition): a protocol for a phase II randomised controlled trial

2021 ◽  
Vol 6 ◽  
pp. 221
Author(s):  
Sarah Kiguli ◽  
Peter Olopot-Olupot ◽  
Florence Alaroker ◽  
Charles Engoru ◽  
Robert O. Opoka ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Nutritional Support ◽  
Cell Function ◽  
Action Plan ◽  
Controlled Trial ◽  
Severe Pneumonia ◽  
Phase Iii ◽  
Randomised Controlled ◽  
Usual Diet

Background: To prevent poor long-term outcomes (deaths and readmissions) the integrated global action plan for pneumonia and diarrhoea recommends under the ‘Treat’ element of Protect, Prevent and Treat interventions the importance of continued feeding but gives no specific recommendations for nutritional support. Early nutritional support has been practiced in a wide variety of critically ill patients to provide vital cell substrates, antioxidants, vitamins, and minerals essential for normal cell function and decreasing hypermetabolism. We hypothesise that the excess post-discharge mortality associated with pneumonia may relate to the catabolic response and muscle wasting induced by severe infection and inadequacy of the diet to aid recovery. We suggest that providing additional energy-rich, protein, fat and micronutrient ready-to-use therapeutic feeds (RUTF) to help meet additional nutritional requirements may improve outcome. Methods: COAST-Nutrition is an open, multicentre, Phase II randomised controlled trial in children aged 6 months to 12 years hospitalised with suspected severe pneumonia (and hypoxaemia, SpO2 <92%) to establish whether supplementary feeds with RUTF given in addition to usual diet for 56-days (experimental) improves outcomes at 90-days compared to usual diet alone (control). Primary endpoint is change in mid-upper arm circumference (MUAC) at 90 days and/or as a composite with 90-day mortality. Secondary outcomes include anthropometric status, mortality, readmission at days 28 and 180. The trial will be conducted in four sites in two countries (Uganda and Kenya) enrolling 840 children followed up to 180 days. Ancillary studies include cost-economic analysis, molecular characterisation of bacterial and viral pathogens, evaluation of putative biomarkers of pneumonia, assessment of muscle and fat mass and host genetic studies.   Discussion: This study is the first step in providing an option for nutritional support following severe pneumonia and will help in the design of a large Phase III trial. Registration: ISRCTN10829073 (6th June 2018) PACTR202106635355751 (2nd June 2021)

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