Protein Intake Associated With Physical Activity Related to Specific Outcomes

Not Applicable

• Conditions: Cancer; Critically Ill; Surgery
• Interventions: Dietary Supplement: Intervention; Dietary Supplement: Control

• Registration Number: NCT03438201
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-01-29
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-15
• Last Update Submitted: 2018-02-15
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19
• Study Start: 2018-04-04
• Primary Completion: 2018-10-12
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

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;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-protein diet	Intervention	High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol
Normoproteic diet	Control	Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol

Primary Outcome Measures

Name	Time	Method
Physical Function	8 days after randomization	6 minutes walk test

Secondary Outcome Measures

Name	Time	Method
Physical Function	30 days after randomization	6-minute walk test after 30 days the date of randomization;
Quality of life	6 months after randomization	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).
Body Composition related to prognosis	8 days after randomization	Phase Angle (BIA)
Postoperative complications	30 days after randomization	Clavien Dindo
Resting Energy Expenditure	one day before surgery and one day after surgery	Indirect Calorimetry
Length of hospital stay.	30 days after randomization	Starts in the first day of hospitalization and ends on the day of hospital discharge

Trial Locations

Locations (1)

Faculty of Medicine University of Sao Paulo; 🇧🇷 São Paulo, SP, Brazil