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Trial record 33 of 88 for:    lung cancer AND risk factors

Evolution of Corporeal Composition in the PeriOperative Period (ECCOP)

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: NCT02143869
Recruitment Status : Active, not recruiting
First Posted : May 21, 2014
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Denutrition and Obesity are risk factors for perioperative surgical complications.

In patient with cancer, incidence of denutrition is markedly increased. Surgical resection of cancer induces a high intensity cellular stress response and catabolism reinforcing the risk for perioperative denutrition.

In this study, we thought to investigate the change in body composition during the perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis (BIA).


Condition or disease Intervention/treatment
Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal) Lung Cancer Device: Bioelectrical Impedance Analysis

Detailed Description:

Body composition measurements will be performed before surgical procedure (7 days) and at day 1, day 5, 1 month, 3 months and 6 months after surgery.

Others data will be recorded including anthropometric measurements, nutritional intake, occurence of surgical complication, type of surgical procedure, type and stage of cancer, and CT-scan measurements of subcutaneous abdominal fat, visceral fat and peri-renal fat before surgery and at 6 months.


Study Design

Study Type : Observational
Actual Enrollment : 374 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Body Composition Changes in Patients Undergoing Gastrointestinal or Lung Cancer Surgery
Study Start Date : December 2013
Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: Bioelectrical Impedance Analysis
    Measurements of body composition including fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water.

Outcome Measures

Primary Outcome Measures :
  1. body composition [ Time Frame: 1 month ]
    The primary objective is to study the change in body composition (fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water) during the perioperative period with respect to short, mid and long term outcome.


Secondary Outcome Measures :
  1. perioperative complications [ Time Frame: 6 months ]
    One of the secondary objective is to investigate the relationship between baseline body composition and the occurrence of surgical complications.


Other Outcome Measures:
  1. nutritional intake during perioperative period [ Time Frame: 1 month ]
    One of the secondary objective is to investigate the relationship between change in body composition and perioperative nutritional intake.

  2. cancer type and stage [ Time Frame: 6 months ]
    One of the secondary objective is to investigate the relationship between baseline body composition and the type and stage of cancer.

  3. comparison of the body composition obtained by BIA and anthropometric measurements. [ Time Frame: 6 months ]
    One of the secondary objective is to compare the body composition obtained by Bioelectrical Impedance Analysis (BIA) and by anthropometric measurements.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal) or lung cancer undergoing curative surgical resection as part of their disease management.
Criteria

Inclusion Criteria:

  • Gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal)
  • Or Lung cancer
  • And planned surgical resection
  • Age > 18 years

Exclusion Criteria:

  • Surgical procedure planned < 48 h
  • Pregnancy
  • Presence of a cardiac stimulator
Contacts and Locations

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): NCT02143869


Locations
France
Hôpital Européen Marseille
Marseille, France
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Principal Investigator: Jérôme ALLARDET-SERVENT, MD, MSc Hôpital Européen Marseille
More Information

Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT02143869     History of Changes
Other Study ID Numbers: 2013-A01346-39
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Jerome Allardet-Servent, MD, Hôpital Européen Marseille:
Gastrointestinal cancer
Lung cancer
Bioelectrical Impedance analysis
Body composition
Perioperative

Additional relevant MeSH terms:
Lung Neoplasms
Gastrointestinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Digestive System Neoplasms
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases