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Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.
Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard hypercaloric, hyperproteic oral supplement | Active Comparator | Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement) |
|
| Leucin-enriched hypercaloric, hyperproteic oral supplement | Active Comparator | Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard hypercaloric hyperproteic oral nutritional supplement | Dietary Supplement | Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass gain | Changes in Muscle mass (%) determined by BIA and echography | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Fat mass change | Changes in fast mass (%) determined by BIA and echography | 3 Months |
| Phase angle change | Changes in phase angle determined by BIA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aura D Herrera Martinez, PhD | IMIBIC-HURS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMIBIC | Córdoba | Cordoba | 14004 | Spain |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Leucine-enriched hypercaloric hyperproteic oral nutritional supplement | Dietary Supplement | Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement |
|
| 3 Months |
| Changes in albumin | Changes in serum albumin levels (g/dL) | 3 Months |
| Changes in prealbumin | Changes in serum prealbumin levels (mg/dL) | 3 Months |
| Changes in CRP | Changes in serum CRP levels (g/L) | 3 Months |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |