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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-protein diet | Active Comparator | High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol |
|
| Normoproteic diet | Active Comparator | Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Dietary Supplement | Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | 6 minutes walk test | 8 days after randomization |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliano P Almeida, Professor | Contact | (5511) 98149-2592 | doctorjuliano@yahoo.com.br | |
| Ilana Roitman, RD | Contact | (5511) 98322-8123 | ilanaroitman88@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juliano P Almeida, Professor | University of Sao Paulo | Principal Investigator |
| Ilana Roitman | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine University of Sao Paulo | São Paulo | São Paulo | 01246-903 | Brazil |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D016638 | Critical Illness |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Control | Dietary Supplement | Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day |
|
|
| 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 |