The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
126
125 mL Fortimel/Nutridrink Compact Protein®\* two servings per day (300 kcal, 18 g protein per serving).
UZ Gent
Ghent, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
North Estonia Medical Centre
Tallinn, Estonia
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.
Time frame: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
Time frame: end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Change of body weight.
change of body weight measured with weighting scale
Time frame: during 12 weeks (baseline till end of intervention at week 12]
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Tartu University Hospital
Tartu, Estonia
National Cancer Institute
Vilnius, Lithuania
Amphia Ziekenhuis
Breda, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Máxima Medisch Centrum
Veldhoven, Netherlands
Zaans Medisch Centrum
Zaandam, Netherlands
...and 4 more locations