Protein Intake Associated With Physical Activity Related to Specific Outcomes (STRENGTH)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Surgery; Critically Ill
• Intervention / Treatment: Dietary supplement: Intervention; Dietary supplement: Control

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 Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01246-903
      • Faculty of Medicine University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Juliano P Almeida, Professor, University of Sao Paulo; Principal Investigator: Ilana Roitman, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): April 4, 2018
• Primary Completion (Anticipated): October 12, 2018
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cancer, ICU, Surgery, Protein, Physical Activity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 77623917.0.0000.0065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No