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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Tumor

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, cachexia, nutrition, colorectal tumor