CancerNCT02901132
Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients
An observational study of Cancer and Postoperative Complications, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial summary
Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival and quality of life. The etiology of malnutrition in cancer patients is multifactorial, therefore, the nutritional assessment should be carried out by different parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Postoperative Complications, Sarcopenia
- How many people
- 120 participants
- Where
- 2 sitesBrazil
- Study dates
- Mar 2013to May 2017
- Phase
- Observational
- 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
Study population: Cancer patients that will be submitted a surgical treatment at University Hospital of University Federal of Minas Gerais.
Who may be able to join
- Diagnostic cancer confirmed
- Over 18 years old
- Accepted the terms of survey
Who cannot join
- Tumor synchronic
- Inflamattory disease
- Under 18 years old
- No accepted the terms of survey
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
UFMG Hospital
Belo Horizonte, Minas Gerais, 30640100
Hospital of Clinics of the University Federal of Minas Gerais
Belo Horizonte, Minas Gerais
About this study
Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival and quality of life. The etiology of malnutrition in cancer patients is multifactorial, therefore, the nutritional assessment should be carried out by different parameters. The objective of this study is to investigate the association and prognostic value of five distinct methods of nutritional assessment (molecular, body composition, functional, anthropometric and subjective) in relation to postoperative complications and short-term survival in patients with cancer. Regarding the molecular parameter, mtor signaling pathwayon will be assessed in rectus muscle samples, harvested in the moment of the operation. Body composition was assessed by computed tomography (CT) and bioelectrical impedance test was conducted to evaluate the phase angle. Handgrip strength was used to determine functionality. The percentage of weight loss in relation to usual weight was the anthropometric parameter used. Subjective Global Assessment (SGA) was used to provide the nutritional diagnosis. Postoperative complications were classified according to the Dindo and Clavien classification. Overall time survival was the period between the first assessment of the patients until death or end of follow-up. Chi-square test, t test, Kaplan-Meier method and the Log Rank test and regression analysis will be used (p <0.05).
- Conditions
- Cancer, Postoperative Complications, Sarcopenia
- Medical subject headings
- Neoplasms, Postoperative Complications, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer group 1 | Colorectal cancer patients, under 18 years old, no inflammatory disease, weight loss greater 10% habitual body weight, sarcopenic. | |
| Control group | No cancer patients, under 18 years old, no inflammatory disease, no weight loss, no sarcopenic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
According to the Dindo-Clavien protocol
Measured: August, 2016
Secondary outcomes (1)
Survival
Follow up using medical records and telephone contacts
Measured: July, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startMar 2013
- Primary completionMar 2017
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901132
- Sponsor's protocol ID
- FUMinas Gerais
- Status last verified
- Apr 2017
- First submitted
- 6 Sep 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientific publications
Publications
Mauricio SF, Xiao J, Prado CM, Gonzalez MC, Correia MITD. Different nutritional assessment tools as predictors of postoperative complications in patients undergoing colorectal cancer resection. Clin Nutr. 2018 Oct;37(5):1505-1511. doi: 10.1016/j.clnu.2017.08.026. Epub 2017 Sep 4.
PubMed 28918167
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients
- ClinicalTrials.gov ID
- NCT02901132
- Acronym / sponsor ID
- FUMinas Gerais
- Conditions
- Cancer, Postoperative Complications, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 15 Sep 2016 (estimated)
- 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.
Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival and quality of life. The etiology of malnutrition in cancer patients is multifactorial, therefore, the nutritional assessment should be carried out by different parameters. The objective of this study is to investigate the association and prognostic value of five distinct methods of nutritional assessment (molecular, body composition, functional, anthropometric and subjective) in relation to postoperative complications and short-term survival in patients with cancer. Regarding the molecular parameter, mtor signaling pathwayon will be assessed in rectus muscle samples, harvested in the moment of the operation. Body composition was assessed by computed tomography (CT) and bioelectrical impedance test was conducted to evaluate the phase angle. Handgrip strength was used to determine functionality. The percentage of weight loss in relation to usual weight was the anthropometric parameter used. Subjective Global Assessment (SGA) was used to provide the nutritional diagnosis. Postoperative complications were classified according to the Dindo and Clavien classification. Overall time survival was the period between the first assessment of the patients until death or end of follow-up. Chi-square test, t test, Kaplan-Meier method and the Log Rank test and regression analysis will be used (p <0.05).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer group 1 | – | –Colorectal cancer patients, under 18 years old, no inflammatory disease, weight loss greater 10% habitual body weight, sarcopenic. |
| Control group | – | –No cancer patients, under 18 years old, no inflammatory disease, no weight loss, no sarcopenic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients that will be submitted a surgical treatment at University Hospital of University Federal of Minas Gerais.
Key inclusion criteria (3 listed)
- Diagnostic cancer confirmed
- Over 18 years old
- Accepted the terms of survey
Key exclusion criteria (4 listed)
- Tumor synchronic
- Inflamattory disease
- Under 18 years old
- No accepted the terms of survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complications
Time frame: August, 2016
According to the Dindo-Clavien protocol
1 secondary outcome
Survival
Time frame: July, 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Derived from this study: PubMed 28918167Mauricio SF, Xiao J, Prado CM, Gonzalez MC, Correia MITD. Different nutritional assessment tools as predictors of postoperative complications in patients undergoing colorectal cancer resection. Clin Nutr. 2018 Oct;37(5):1505-1511. doi: 10.1016/j.clnu.2017.08.026. Epub 2017 Sep 4.
- Individual participant dataSharing planned: Yes. Scientific publications
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Postoperative Complications, run by Federal University of Minas Gerais at 2 sites 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 3 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: August, 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02901132, which also lists 1 linked publication.
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 11 Apr 2017.