Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: Experimental group (experimental nutritional oral supplement); and Control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
160
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber and omega-3 enriched, with L-leucine, betaglucans and medium chain triglycerides) for 8 weeks.
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber) for 8 weeks.
Institute for Health Research IdiPAZ
Madrid, Spain
Nutritional status
Subjective Global Assessment (SGA)
Time frame: Change from baseline to day 142
Diet quality
72h food registry questionaire
Time frame: Change from baseline to day 142
Functional status
Dinamometer
Time frame: Change from baseline to day 142
Eastern Cooperative Oncology Group Scale (ECOG)
Eastern Cooperative Oncology Group Scale (ECOG)
Time frame: Change from baseline to day 142
Body composition
BIA
Time frame: Change from baseline to day 142
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