Protein Intake Associated With Physical Activity Related to Specific Outcomes

Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03438201
• Other study ID #: 77623917.0.0000.0065
• Status: Not yet recruiting
• Phase: N/A
• First received: January 29, 2018
• Last updated: February 15, 2018
• Start date: April 4, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: February 2018
• Source: University of Sao Paulo
• Contact: Juliano P Almeida, Professor
• Phone: (5511) 98149-2592
• Email: doctorjuliano[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: April 30, 2020
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Critical Illness
• Critically Ill
• Surgery

Intervention

Dietary Supplement:
• Intervention
Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day
• Control
Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day

Locations

Country	Name	City	State
Brazil	Faculty of Medicine University of Sao Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Function	6 minutes walk test	8 days after randomization
Secondary	Physical Function	6-minute walk test after 30 days the date of randomization;	30 days after randomization
Secondary	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
Secondary	Body Composition related to prognosis	Phase Angle (BIA)	8 days after randomization
Secondary	Postoperative complications	Clavien Dindo	30 days after randomization
Secondary	Resting Energy Expenditure	Indirect Calorimetry	one day before surgery and one day after surgery
Secondary	Length of hospital stay.	Starts in the first day of hospitalization and ends on the day of hospital discharge	30 days after randomization