Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery (ANC2)

November 20, 2018 updated by: Hospices Civils de Lyon

ANC2 Pilot Study Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery

Cachexia associated with cancer is a grave and most of the time irreversible common situation. It seems independent from the size of the tumor or from its metastatic character. The consequences for the management of the patient are major and exceed widely the frame of the nutrition.

Undernutrition of patients with cancer is described by a decrease of the energy contributions and a loss of muscular and fat mass, leading to a progressive functional deficiency which can go to the cachectic state.

Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia but it remain too indistinct to allow an early and efficient screening and set up effective measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast iron of the energy reserves.

It is necessary to have clinical and biological markers with diagnostic aim and forecasts during the situations precedents the appearance of cachexia.

The present study will allow calibrating a longitudinal study, which could confirm the value of measures made for the diagnosis of pre-cachexia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre Benite, France, 69495
        • Groupement Hospitalier Sud - Service de Médecine Gériatrique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥ 70 years
  • Colorectal tumor resection with/without synchronous metastases

Exclusion Criteria:

  • Emergency resection of colorectal tumor
  • Unresectable colorectal tumor with/without synchronous metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with colorectal surgery
Other: Blood sampling
Procedure: Biopsy of adipose and muscular tissue
Other: Calorimetry
Other: Impedance measure
Evaluation of physical composition (non-invasive method)
Other: Evaluation of nutritional status
Nutritional status will be assessed by using the "Mini Nutritional Assessment" (MNA) questionnaire and a scale that evaluates anorexia
Other: Evaluation of physical performance
This will be assessed by using a "tiredness scale" named "Echelle Visuelle Analogique" (EVA) in french
Other: Evaluation of muscular strength
Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)
Other: Evaluation of emotional status
The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)
Other: Evaluation of functional status
The functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biological and radiological markers
Time Frame: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
Validated criteria of cachexia, pre-cachexia and sarcopenia are applied. Systematic preoperative measures (TNFα, leptin, ghrelin) and CT scanning of the abdomen/pelvis are performed for all patient enrolled.
During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
activity of the ATGL
Time Frame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
The activity of ATGL is determined by liquid scintillation counting.
During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Body composition
Time Frame: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
Body composition is evaluated utilizing computerized tomography(CT) images (at the third lumbar vertebral level). A muscle index is also calculated by normalizing muscle areas for height.
During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
metabolic phenotype
Time Frame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
metabolic phenotype is determinated by indirect calorimetry.
During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
loss of fat body mass and/or lean body mass
Time Frame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Lean body mass and components (intracellular water and extracellular water as well as body cell mass) were calculated by tetrapolar bioelectrical impedance analysis
During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2013

Primary Completion (Actual)

February 7, 2018

Study Completion (Actual)

March 7, 2018

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.752
  • 2012-A01017-36 (Registry Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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