CancerSTRENGTHNCT03438201
Protein Intake Associated With Physical Activity Related to Specific Outcomes
A study testing Intervention in people with Cancer and Critically Ill, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Critically Ill, Surgery
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Apr 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Medicine University of Sao Paulo
São Paulo, São Paulo, 01246-903
Ilana Roitman, RD, (5511) 98322-8123, ilanaroitman88@gmail.com
Juliano P Alemida, Professor, (5511) 98149-2592, doctorjuliano@yahoo.com.br
About this study
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
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.
Read the 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.
- Conditions
- Cancer, Critically Ill, Surgery
- Being tested
- Intervention, Control
- Keywords
- Cancer, ICU, Surgery, Protein, Physical Activity
- Medical subject headings
- Neoplasms, Critical Illness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDietary supplement
Also called High Protein intake
Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day
ControlDietary supplement
Also called Standard Protein Intake
Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day
| Study group | Role | What they receive |
|---|---|---|
| High-protein diet | Active comparator | High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol Receives: Dietary Supplement: Intervention |
| Normoproteic diet | Active comparator | Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function
6 minutes walk test
Measured: 8 days after randomization
Secondary outcomes (6)
Physical Function
6-minute walk test after 30 days the date of randomization;
Measured: 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).
Measured: 6 months after randomization
Body Composition related to prognosis
Phase Angle (BIA)
Measured: 8 days after randomization
Postoperative complications
Clavien Dindo
Measured: 30 days after randomization
Resting Energy Expenditure
Indirect Calorimetry
Measured: 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
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start4 Apr 2018 (estimated)
- Primary completion12 Oct 2018 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliano P Almeida, MD, PhD, University of Sao Paulo
- Investigators
- Juliano P Almeida, Professor, Principal investigator, University of Sao PauloIlana Roitman, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438201
- Sponsor's protocol ID
- 77623917.0.0000.0065
- Acronym
- STRENGTH
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03438201
- Acronym / sponsor ID
- STRENGTH / 77623917.0.0000.0065
- Conditions
- Cancer, Critically Ill, Surgery
- Keywords
- Cancer, ICU, Surgery, Protein, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 4 Apr 2018 (estimated)
- Primary completion
- 12 Oct 2018 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-protein diet | Active comparator | Dietary Supplement: InterventionHigh Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol |
| Normoproteic diet | Active comparator | Dietary Supplement: ControlStandard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: High Protein intakeEnteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day | Dietary supplement | High-protein diet |
| ControlAlso: Standard Protein IntakeEnteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day | Dietary supplement | Normoproteic diet |
Primary outcome
Physical Function
Time frame: 8 days after randomization
6 minutes walk test
6 secondary outcomes
Physical Function
Time frame: 30 days after randomization
Quality of life
Time frame: 6 months after randomization
Body Composition related to prognosis
Time frame: 8 days after randomization
Postoperative complications
Time frame: 30 days after randomization
Resting Energy Expenditure
Time frame: one day before surgery and one day after surgery
Length of hospital stay.
Time frame: 30 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliano P Almeida, Professor principal investigator
University of Sao Paulo
Ilana Roitman principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cancer and Critically Ill, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliano P Almeida, Professor ((5511) 98149-2592, doctorjuliano@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function (time frame: 8 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.