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)
Primary Purpose
Colorectal Tumor
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy of adipose and muscular tissue
Blood sampling
Calorimetry
Impedance measure
Evaluation of nutritional status
Evaluation of physical performance
Evaluation of muscular strength
Evaluation of emotional status
Evaluation of functional status
Sponsored by
About this trial
This is an interventional other trial for Colorectal Tumor focused on measuring cachexia, nutrition, cancer, colorectal tumor
Eligibility Criteria
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
Sites / Locations
- Groupement Hospitalier Sud - Service de Médecine Gériatrique
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with colorectal surgery
Arm Description
Outcomes
Primary Outcome Measures
biological and radiological markers
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.
Secondary Outcome Measures
activity of the ATGL
The activity of ATGL is determined by liquid scintillation counting.
Body composition
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.
metabolic phenotype
metabolic phenotype is determinated by indirect calorimetry.
loss of fat body mass and/or lean body mass
Lean body mass and components (intracellular water and extracellular water as well as body cell mass) were calculated by tetrapolar bioelectrical impedance analysis
Full Information
NCT ID
NCT02199912
First Posted
June 26, 2014
Last Updated
November 20, 2018
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02199912
Brief Title
Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery
Acronym
ANC2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 7, 2013 (Actual)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
March 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Tumor
Keywords
cachexia, nutrition, cancer, colorectal tumor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with colorectal surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Biopsy of adipose and muscular tissue
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Type
Other
Intervention Name(s)
Calorimetry
Intervention Type
Other
Intervention Name(s)
Impedance measure
Intervention Description
Evaluation of physical composition (non-invasive method)
Intervention Type
Other
Intervention Name(s)
Evaluation of nutritional status
Intervention Description
Nutritional status will be assessed by using the "Mini Nutritional Assessment" (MNA) questionnaire and a scale that evaluates anorexia
Intervention Type
Other
Intervention Name(s)
Evaluation of physical performance
Intervention Description
This will be assessed by using a "tiredness scale" named "Echelle Visuelle Analogique" (EVA) in french
Intervention Type
Other
Intervention Name(s)
Evaluation of muscular strength
Intervention Description
Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)
Intervention Type
Other
Intervention Name(s)
Evaluation of emotional status
Intervention Description
The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)
Intervention Type
Other
Intervention Name(s)
Evaluation of functional status
Intervention Description
The functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire
Primary Outcome Measure Information:
Title
biological and radiological markers
Description
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.
Time Frame
During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
Secondary Outcome Measure Information:
Title
activity of the ATGL
Description
The activity of ATGL is determined by liquid scintillation counting.
Time Frame
During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Title
Body composition
Description
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.
Time Frame
During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
Title
metabolic phenotype
Description
metabolic phenotype is determinated by indirect calorimetry.
Time Frame
During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Title
loss of fat body mass and/or lean body mass
Description
Lean body mass and components (intracellular water and extracellular water as well as body cell mass) were calculated by tetrapolar bioelectrical impedance analysis
Time Frame
During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Groupement Hospitalier Sud - Service de Médecine Gériatrique
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery
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