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

Colorectal Tumor Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199912
• Other study ID #: 2012.752
• Secondary ID: 2012-A01017-36
• Status: Completed
• Phase: N/A
• Start date: October 7, 2013
• Est. completion date: March 7, 2018

Study information

• Verified date: November 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Colorectal Neoplasms
• Colorectal Tumor

Intervention

Procedure:
• Biopsy of adipose and muscular tissue

Other:
• Blood sampling

• Calorimetry

• Impedance measure
Evaluation of physical composition (non-invasive method)
• Evaluation of nutritional status
Nutritional status will be assessed by using the "Mini Nutritional Assessment" (MNA) questionnaire and a scale that evaluates anorexia
• Evaluation of physical performance
This will be assessed by using a "tiredness scale" named "Echelle Visuelle Analogique" (EVA) in french
• Evaluation of muscular strength
Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)
• Evaluation of emotional status
The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)
• 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

Locations

Country	Name	City	State
France	Groupement Hospitalier Sud - Service de Médecine Gériatrique	Pierre Benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biological and radiological markers	Validated criteria of cachexia, pre-cachexia and sarcopenia are applied. Systematic preoperative measures (TNFa, 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	activity of the ATGL	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)
Secondary	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.	During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
Secondary	metabolic phenotype	metabolic phenotype is determinated by indirect calorimetry.	During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Secondary	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	During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)