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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).
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Trials

ISSN: 1745-6215