An interventional study of Intervention and Control in Cancer, Critically Ill and Surgery, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 126 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol
Dietary Supplement: Intervention
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 2.0 - 2.5 Kg/body weight/Day
Also known as: High Protein intake
Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day
Also known as: Standard Protein Intake
Physical Function
6 minutes walk test
Time frame: 8 days after randomization
Physical Function
6-minute walk test after 30 days the date of randomization;
Time frame: 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).
Time frame: 6 months after randomization
Body Composition related to prognosis
Phase Angle (BIA)
Time frame: 8 days after randomization
Postoperative complications
Clavien Dindo
Time frame: 30 days after randomization
Resting Energy Expenditure
Indirect Calorimetry
Time frame: 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
Time frame: 30 days after randomization
Start is estimated for Apr 2018; primary completion for Oct 2018, 6 months later.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 6 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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