Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition

Study Overview
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Brief Summary
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Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition

Detailed Description
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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).

Official Title
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A Clinical Trial With Nutritional Intervention to Evaluate the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Patients With Cancer and Malnutrition

Conditions
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Malnutrition, Cancer, Nutrition Related Cancer

Intervention / Treatment
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* Dietary Supplement: Experimental Group
* Dietary Supplement: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over 18 with a cancer diagnosis (any type). Subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery. Having lost more than 5% of body weight in the last 6 months. Adequate cultural level and understanding for the clinical trial. Signed informed consent. Exclusion Criteria: Subjects who are participating in other clinical trials. Subjects with morbid obesity. Subjects who will undergo surgery or who will undergo. Subjects with cachexia Subjects with infection of a cause other than of the tumor Subjects with an infectious process Subjects with Diabetes Mellitus treated with insulin and/or not controlled Subjects with kidney, heart, respiratory or liver disease. Subjects with autoimmune diseases. Subjects with mental illness or decrease function cognitive. Subjects who consume oral supplements or artificial nutrition and who cannot be withdran at least 1 week before startint the study. Patients who have consumed food supplements or fortified foods in omega 3 (arginine or nucleotides) during the previous month. Patients who reject oral supplements. Pregnant or breastfeeding women. Allergic to any component of the formula

Ages Eligible for Study
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Minimum Age: 28 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement | Dietary Supplement: Experimental Group<br>* 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.<br>|
| Active Comparator: Control group<br>Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement | Dietary Supplement: Control Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Subjective Global Assessment (SGA) | Change from baseline to day 142 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, cancer, nutrition, nutritional oral supplement, clinical trial