Skip to main content

Table 2 A schematic diagram of time schedule for enrolment, interventions, assessments, and visits for participants

From: Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial

  Pre-randomization (day -7 to day 0): Check inclusion and exclusion criteria
Zelen's randomization
Parenteral nutrition group Oral feeding group
Present "parenteral nutrition" info Present "oral feeding" info
Day 1 Days 2-60* Day 61-death** Day 1 Days 2-60* Day 61-death**
Obtain informed consent X    X   
Record demographic data X    X   
Take medical history X    X   
Treatment       
Concomitant treatments X X   X X  
Specific treatment (prior or ongoing) X X   X X  
Patient status       
WHO Status X X X X X X
Karnofsky index X X   X X  
Estimated life expectancy X    X   
Anthropometric data       
Height X    X   
Weight X X X X X X
Biology       
Lactic acid dehydrogenase X    X   
C-reactive protein, albumin, prealbumin X X   X X  
Blood count, electrolytes (including phosphorus, calcium, magnesium) X X     
Hepatic enzymes (AST, ALT, PAL, Gamma GT, Bilirubin) X X     
Triglycerides X X     
Ketonuria, glycosuria X X     
Quality of life questionnaires (QLQ-C15-PAL and QUAL-E***) X X X X X X
Socio-economic variables X    X   
Dietetics consultation X    X   
Ingesta questionnaire   X X   X X
Evaluation of metastatic disease   X    X  
Intervention supportive care   X    X  
  1. *Follow-up consultation at least once per month **Evaluation once per month. ***Administer the QUAL-E if the patients consider themselves to be at the end of life (definition at the discretion of the physician and patient).