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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438201
Recruitment Status : Unknown
Verified February 2018 by Juliano P Almeida, MD, PhD, University of Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Juliano P Almeida, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Cancer Critically Ill Surgery Dietary Supplement: Intervention Dietary Supplement: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 4, 2018
Estimated Primary Completion Date : October 12, 2018
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Standard Protein Intake




Primary Outcome Measures :
  1. Physical Function [ Time Frame: 8 days after randomization ]
    6 minutes walk test


Secondary Outcome Measures :
  1. Physical Function [ Time Frame: 30 days after randomization ]
    6-minute walk test after 30 days the date of randomization;

  2. Quality of life [ Time Frame: 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).

  3. Body Composition related to prognosis [ Time Frame: 8 days after randomization ]
    Phase Angle (BIA)

  4. Postoperative complications [ Time Frame: 30 days after randomization ]
    Clavien Dindo

  5. Resting Energy Expenditure [ Time Frame: one day before surgery and one day after surgery ]
    Indirect Calorimetry

  6. Length of hospital stay. [ Time Frame: 30 days after randomization ]
    Starts in the first day of hospitalization and ends on the day of hospital discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438201


Contacts
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Contact: Juliano P Almeida, Professor (5511) 98149-2592 doctorjuliano@yahoo.com.br
Contact: Ilana Roitman, RD (5511) 98322-8123 ilanaroitman88@gmail.com

Locations
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Brazil
Faculty of Medicine University of Sao Paulo
São Paulo, SP, Brazil, 01246-903
Contact: Ilana Roitman, RD    (5511) 98322-8123    ilanaroitman88@gmail.com   
Contact: Juliano P Alemida, Professor    (5511) 98149-2592    doctorjuliano@yahoo.com.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Juliano P Almeida, Professor University of Sao Paulo
Principal Investigator: Ilana Roitman University of Sao Paulo
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Responsible Party: Juliano P Almeida, MD, PhD, Medical Doctor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03438201    
Other Study ID Numbers: 77623917.0.0000.0065
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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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
Keywords provided by Juliano P Almeida, MD, PhD, University of Sao Paulo:
Cancer, ICU, Surgery, Protein, Physical Activity
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes