NCT02143869

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

May 18, 2014

Last Update Submit

September 3, 2019

Conditions

Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal)Lung Cancer

Keywords

Gastrointestinal cancerLung cancerBioelectrical Impedance analysisBody compositionPerioperative

Outcome Measures

Primary Outcomes (1)

  • body composition

    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.

    1 month

Secondary Outcomes (1)

  • perioperative complications

    6 months

Other Outcomes (3)

  • nutritional intake during perioperative period

    1 month

  • cancer type and stage

    6 months

  • comparison of the body composition obtained by BIA and anthropometric measurements.

    6 months

Interventions

Bioelectrical Impedance AnalysisDEVICE

Measurements of body composition including fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Surgical procedure planned \< 48 h
  • Pregnancy
  • Presence of a cardiac stimulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Européen Marseille

Marseille, France

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jérôme ALLARDET-SERVENT, MD, MSc

    Hôpital Européen Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

May 18, 2014

First Posted

May 21, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

September 1, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

FR(1)