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| Name | Class |
|---|---|
| Adventia Pharma | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement |
|
| Control group | Active Comparator | Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status | Subjective Global Assessment (SGA) | Change from baseline to day 142 |
| Measure | Description | Time Frame |
|---|---|---|
| Diet quality | 72h food registry questionaire | Change from baseline to day 142 |
| Functional status | Dinamometer | Change from baseline to day 142 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gómez Candela, Msc | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Health Research IdiPAZ | Madrid | 28046 | Spain |
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| Control Group | Dietary Supplement | 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. |
|
| Eastern Cooperative Oncology Group Scale (ECOG) | Eastern Cooperative Oncology Group Scale (ECOG) | Change from baseline to day 142 |
| Body composition | BIA | Change from baseline to day 142 |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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