Protein Intake Associated With Physical Activity Related to Specific Outcomes

NCT ID: NCT03438201

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2020-04-30

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.

Conditions

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Cancer Critically Ill Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High-protein diet

High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol

Group Type ACTIVE_COMPARATOR

Intervention

Intervention Type DIETARY_SUPPLEMENT

Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day

Normoproteic diet

Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day

Interventions

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Intervention

Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day

Intervention Type DIETARY_SUPPLEMENT

Control

Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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High Protein intake Standard Protein Intake

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Juliano P Almeida, MD, PhD

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juliano P Almeida, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Ilana Roitman

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Faculty of Medicine University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Juliano P Almeida, Professor

Role: CONTACT

(5511) 98149-2592

Ilana Roitman, RD

Role: CONTACT

(5511) 98322-8123

Facility Contacts

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Ilana Roitman, RD

Role: primary

(5511) 98322-8123

Juliano P Alemida, Professor

Role: backup

(5511) 98149-2592

Other Identifiers

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77623917.0.0000.0065

Identifier Type: -

Identifier Source: org_study_id

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