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

Primary Purpose

Cancer, Critically Ill, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, ICU, Surgery, Protein, Physical Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High-protein diet

Normoproteic diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Physical Function
6 minutes walk test

Secondary Outcome Measures

Physical Function
6-minute walk test after 30 days the date of 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).
Body Composition related to prognosis
Phase Angle (BIA)
Postoperative complications
Clavien Dindo
Resting Energy Expenditure
Indirect Calorimetry
Length of hospital stay.
Starts in the first day of hospitalization and ends on the day of hospital discharge

Full Information

First Posted
January 29, 2018
Last Updated
February 15, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03438201
Brief Title
Protein Intake Associated With Physical Activity Related to Specific Outcomes
Acronym
STRENGTH
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2018 (Anticipated)
Primary Completion Date
October 12, 2018 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Critically Ill, Surgery
Keywords
Cancer, ICU, Surgery, Protein, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-protein diet
Arm Type
Active Comparator
Arm Description
High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol
Arm Title
Normoproteic diet
Arm Type
Active Comparator
Arm Description
Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention
Other Intervention Name(s)
High Protein intake
Intervention Description
Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Other Intervention Name(s)
Standard Protein Intake
Intervention Description
Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day
Primary Outcome Measure Information:
Title
Physical Function
Description
6 minutes walk test
Time Frame
8 days after randomization
Secondary Outcome Measure Information:
Title
Physical Function
Description
6-minute walk test after 30 days the date of randomization;
Time Frame
30 days after randomization
Title
Quality of life
Description
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).
Time Frame
6 months after randomization
Title
Body Composition related to prognosis
Description
Phase Angle (BIA)
Time Frame
8 days after randomization
Title
Postoperative complications
Description
Clavien Dindo
Time Frame
30 days after randomization
Title
Resting Energy Expenditure
Description
Indirect Calorimetry
Time Frame
one day before surgery and one day after surgery
Title
Length of hospital stay.
Description
Starts in the first day of hospitalization and ends on the day of hospital discharge
Time Frame
30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliano P Almeida, Professor
Phone
(5511) 98149-2592
Email
doctorjuliano@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Ilana Roitman, RD
Phone
(5511) 98322-8123
Email
ilanaroitman88@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliano P Almeida, Professor
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilana Roitman
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine University of Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246-903
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Roitman, RD
Phone
(5511) 98322-8123
Email
ilanaroitman88@gmail.com
First Name & Middle Initial & Last Name & Degree
Juliano P Alemida, Professor
Phone
(5511) 98149-2592
Email
doctorjuliano@yahoo.com.br

12. IPD Sharing Statement

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Protein Intake Associated With Physical Activity Related to Specific Outcomes

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