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NCT Number: NCT02199912

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

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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupement Hospitalier Sud - Service de Médecine Gériatrique

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy of adipose and muscular tissue

Procedure

Blood sampling

Other

Calorimetry

Other

Impedance measure

Other

Evaluation of physical composition (non-invasive method)

Evaluation of nutritional status

Other

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

Evaluation of physical performance

Other

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

Evaluation of muscular strength

Other

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

Evaluation of emotional status

Other

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

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

Primary outcomes

  1. biological and radiological markers

    Time frame: 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 outcomes

  1. activity of the ATGL

    Time frame: 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.

  2. Body composition

    Time frame: 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.

  3. metabolic phenotype

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

    metabolic phenotype is determinated by indirect calorimetry.

  4. loss of fat body mass and/or lean body mass

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: ANC2

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 25, 2014
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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