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

NCT02199912 | Completed

• 2 other identifiers: 2012.7522012-A01017-36
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Tumor

Keywords

cachexia; nutrition; cancer; colorectal tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• activity of the ATGL

  During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)

• Body composition

  During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)

• metabolic phenotype

  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

  During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)

Study Arms (1)

Patients with colorectal surgery

EXPERIMENTAL

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

Interventions

Biopsy of adipose and muscular tissue PROCEDURE

Patients with colorectal surgery

Blood sampling OTHER

Patients with colorectal surgery

Calorimetry OTHER

Patients with colorectal surgery

Impedance measure OTHER

Evaluation of physical composition (non-invasive method)

Patients with colorectal surgery

Evaluation of nutritional status OTHER

Nutritional status will be assessed by using the "Mini Nutritional Assessment" (MNA) questionnaire and a scale that evaluates anorexia

Patients with colorectal surgery

Evaluation of physical performance OTHER

This will be assessed by using a "tiredness scale" named "Echelle Visuelle Analogique" (EVA) in french

Patients with colorectal surgery

Evaluation of muscular strength OTHER

Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)

Patients with colorectal surgery

Evaluation of emotional status OTHER

The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)

Patients with colorectal surgery

Evaluation of functional status OTHER

The functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire

Patients with colorectal surgery

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Groupement Hospitalier Sud - Service de Médecine Gériatrique

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Cachexia; Neoplasms

Interventions

Blood Specimen Collection; Calorimetry

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Chemistry Techniques, Analytical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: July 25, 2014
• Study Start: October 7, 2013
• Primary Completion: February 7, 2018
• Study Completion: March 7, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

FR (1)