Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

Study Overview
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Brief Summary
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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.

Detailed Description
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Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required

Official Title
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Standard Hypercaloric, Hyperproteic vs Leucine-enriched Oral Supplements in Patients With Cancer-induced Sarcopenia

Conditions
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Sarcopenia, Cancer

Intervention / Treatment
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* Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement
* Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of both sexes, age > 18 y-old cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t weight loss >5% during the previous three months or >10% during the previous six months Exclusion Criteria: end-stage kidney disease life expectancy < 2 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard hypercaloric, hyperproteic oral supplement<br>Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement) | Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement<br>* Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement<br>|
| Active Comparator: Leucin-enriched hypercaloric, hyperproteic oral supplement<br>Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement) | Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement<br>* Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass gain | Changes in Muscle mass (%) determined by BIA and echography | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Cancer