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ANC2
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
Sponsor study identifier
Secondary identifiers
REGISTRY · Agence Nationale de Sécurité du Médicament et des produits de santé
interventional
59
1 country
1
Study Start
October 7, 2013
Actual (reported)Primary Completion
February 7, 2018
Actual (reported)Study Completion
March 7, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 7, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2013
Actual (reported)June 26, 2014
Actual (reported)July 25, 2014
Actual (reported)February 7, 2018
Actual (reported)March 7, 2018
Actual (reported)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)
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)
Groupement Hospitalier Sud - Service de Médecine Gériatrique
Pierre-Bénite, 69495, France
59 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2014
First Posted
July 25, 2014
Study Start
October 7, 2013
Actual (reported)Primary Completion
Evaluation of physical composition (non-invasive method)
Nutritional status will be assessed by using the "Mini Nutritional Assessment" (MNA) questionnaire and a scale that evaluates anorexia
This will be assessed by using a "tiredness scale" named "Echelle Visuelle Analogique" (EVA) in french
Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)
The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)
The functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
February 7, 2018
Actual (reported)Study Completion
March 7, 2018
Actual (reported)Last Updated
November 23, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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