Protein Intake Associated With Physical Activity Related to Specific Outcomes

Study Overview
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Brief Summary
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This is a Randomized Controlled Trial . The purpose of this study is to assess the hypothesis that whether a high protein diet combined with a physical activity protocol in surgical cancer patients admitted to the ICU in the post operative period is associated with better physical function at the hospital discharge as well as a better quality of life.

Detailed Description
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Surgical cancer patients will be categorized by their nutritional risk using a specific screening toll. During the hospital stay some measurements will be done. Such as resting energy expenditure (REE) before and after surgery; physical function evaluation; strength and quality of life. The proposed intervention is a post operative diet with a different amount of protein (diet with a standard amount of protein and a diet with high amount of protein) associated to an institutional protocol of physical activity.

Official Title
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The Efficiency of Different Amount of Protein Intake Associated With a Physical Activity Protocol in Surgical Cancer Patients Admitted to the Intensive Care Unit : Randomized Controlled Trial

Conditions
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Cancer, Critically Ill, Surgery

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients Age greater than or equal to 18 years old Have a tendency to be admitted to the ICU after the surgery Fill the eligible criteria to start enteral feeding within 72 hours Sign the consent form; Exclusion Criteria: Mechanical ventilation such as fraction of inspired oxygen inspired oxygen fraction (FiO2) >60% or positive end expiratory pressure (PEEP) > 12cm H2O Bronchopleural fistula Karnofsky <50 Participant cannot b enrolled in another study

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High-protein diet<br>High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol | Dietary Supplement: Intervention<br>* Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day<br>* Other names: High Protein intake;|
| Active Comparator: Normoproteic diet<br>Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol | Dietary Supplement: Control<br>* Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day<br>* Other names: Standard Protein Intake;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function | 6 minutes walk test | 8 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function | 6-minute walk test after 30 days the date of randomization; | 30 days after randomization | 
| Quality of life | Measurement of quality of life using the Euro-Qol 5D-5L index. EQ-5D-5L index includes five questions concerning mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A summary utility index value can be computed from subject's response to these five questions. Values range from -0.594 (worst possible health score) to 0 (death) to 1.000 (best health). | 6 months after randomization | 
| Body Composition related to prognosis | Phase Angle (BIA) | 8 days after randomization | 
| Postoperative complications | Clavien Dindo | 30 days after randomization | 
| Resting Energy Expenditure | Indirect Calorimetry | one day before surgery and one day after surgery | 
| Length of hospital stay. | Starts in the first day of hospitalization and ends on the day of hospital discharge | 30 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, ICU, Surgery, Protein, Physical Activity