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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02199912
Acronym
ANC2
Enrollment
59
Registered
2014-07-25
Start date
2013-10-07
Completion date
2018-03-07
Last updated
2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Tumor

Keywords

cachexia, nutrition, cancer, colorectal tumor

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.

Interventions

PROCEDUREBiopsy of adipose and muscular tissue
OTHERBlood sampling
OTHERCalorimetry
OTHERImpedance measure

Evaluation of physical composition (non-invasive method)

OTHEREvaluation of nutritional status

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

OTHEREvaluation of physical performance

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

OTHEREvaluation of muscular strength

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

OTHEREvaluation of emotional status

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

OTHEREvaluation of functional status

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
biological and radiological markersDuring 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

MeasureTime frameDescription
activity of the ATGLDuring 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.
Body compositionDuring 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.
metabolic phenotypeDuring 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 massDuring 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026