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

Not Applicable

Completed

• Conditions: Colorectal Tumor
• Interventions: Procedure: Biopsy of adipose and muscular tissue; Other: Blood sampling; Other: Calorimetry; Other: Impedance measure; Other: Evaluation of nutritional status; Other: Evaluation of physical performance; Other: Evaluation of muscular strength; Other: Evaluation of emotional status; Other: Evaluation of functional status

• Registration Number: NCT02199912
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-07
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-25
• Primary Completion: 2018-02-07
• Study Completion: 2018-03-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with colorectal surgery	Blood sampling	-
Patients with colorectal surgery	Calorimetry	-
Patients with colorectal surgery	Impedance measure	-
Patients with colorectal surgery	Biopsy of adipose and muscular tissue	-
Patients with colorectal surgery	Evaluation of muscular strength	-
Patients with colorectal surgery	Evaluation of functional status	-
Patients with colorectal surgery	Evaluation of nutritional status	-
Patients with colorectal surgery	Evaluation of physical performance	-
Patients with colorectal surgery	Evaluation of emotional status	-

Primary Outcome Measures

Name	Time	Method
biological and radiological markers	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.

Secondary Outcome Measures

Name	Time	Method
activity of the ATGL	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.
metabolic phenotype	During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)	metabolic phenotype is determinated by indirect calorimetry.
loss of fat body mass and/or lean body mass	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
Body composition	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.

Trial Locations

Locations (1)

Groupement Hospitalier Sud - Service de Médecine Gériatrique; 🇫🇷 Pierre Benite, France