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Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients

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: NCT02901132
Recruitment Status : Unknown
Verified April 2017 by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

Brief 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. 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).

Condition or disease
Cancer Postoperative Complications Sarcopenia

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients
Actual Study Start Date : March 2013
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Group/Cohort
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.



Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: August, 2016 ]
    According to the Dindo-Clavien protocol


Secondary Outcome Measures :
  1. Survival [ Time Frame: July, 2016 ]
    Follow up using medical records and telephone contacts


Other Outcome Measures:
  1. mtor signaling pathway [ Time Frame: December, 2016 ]
    mTOR Elisa kits


Biospecimen Retention:   Samples With DNA
Samples of abdominal rectal muscles.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cancer patients that will be submitted a surgical treatment at University Hospital of University Federal of Minas Gerais.
Criteria

Inclusion Criteria:

  • Diagnostic cancer confirmed
  • Over 18 years old
  • Accepted the terms of survey

Exclusion Criteria:

  • Tumor synchronic
  • Inflamattory disease
  • Under 18 years old
  • No accepted the terms of survey

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): NCT02901132


Locations
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Brazil
UFMG Hospital
Belo horizonte, Minas Gerais, Brazil, 30640100
Hospital of Clinics of the University Federal of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Minas Gerais

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Isabel Toulson Davisson Correia, PHD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02901132    
Other Study ID Numbers: FUMinas Gerais
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Scientific publications

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Postoperative Complications
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Pathologic Processes