Colorectal TumorANC2NCT02199912
Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery
A study testing Biopsy of adipose and muscular tissue, Blood sampling and Calorimetry in people with Colorectal Tumor, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Tumor
- What is being tested?
- Biopsy of adipose and muscular tissue, Blood sampling and Calorimetry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2013to 7 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged ≥ 70 years
- Colorectal tumor resection with/without synchronous metastases
Who cannot join
- Emergency resection of colorectal tumor
- Unresectable colorectal tumor with/without synchronous metastases
Trial locations and contacts
1 site in 1 country.
France1 site
Groupement Hospitalier Sud - Service de Médecine Gériatrique
Pierre-Bénite, 69495
About this study
Official 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
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.
Read more
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
- Being tested
- Biopsy of adipose and muscular tissue, Blood sampling, Calorimetry, Impedance measure, Evaluation of nutritional status
- Keywords
- cachexia, nutrition, cancer, colorectal tumor
- Medical subject headings
- Colorectal Neoplasms, Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of adipose and muscular tissueProcedure or surgery
Blood samplingOther
CalorimetryOther
Impedance measureOther
Evaluation of physical composition (non-invasive method)
Evaluation of nutritional statusOther
Nutritional status will be assessed by using the "Mini Nutritional Assessment" (MNA) questionnaire and a scale that evaluates anorexia
Evaluation of physical performanceOther
This will be assessed by using a "tiredness scale" named "Echelle Visuelle Analogique" (EVA) in french
Evaluation of muscular strengthOther
Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)
Evaluation of emotional statusOther
The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)
Evaluation of functional statusOther
The functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal surgery | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
Secondary outcomes (4)
activity of the ATGL
The activity of ATGL is determined by liquid scintillation counting.
Measured: 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.
Measured: 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.
Measured: 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
Measured: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study start7 Oct 2013
- Primary completion7 Feb 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal TumorStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199912
- Sponsor's protocol ID
- 2012.752
- Other IDs
- 2012-A01017-36
- Acronym
- ANC2
- Status last verified
- Nov 2018
- First submitted
- 26 Jun 2014
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02199912
- Acronym / sponsor ID
- ANC2 / 2012.752
- Conditions
- Colorectal Tumor
- Keywords
- cachexia, nutrition, cancer, colorectal tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Oct 2013 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 70 years
- Colorectal tumor resection with/without synchronous metastases
Key exclusion criteria (2 listed)
- Emergency resection of colorectal tumor
- Unresectable colorectal tumor with/without synchronous metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy of adipose and muscular tissue | Procedure or surgery | Patients with colorectal surgery |
| Blood sampling | Other | Patients with colorectal surgery |
| Calorimetry | Other | Patients with colorectal surgery |
| Impedance measureEvaluation of physical composition (non-invasive method) | Other | Patients with colorectal surgery |
| Evaluation of nutritional statusNutritional status will be assessed by using the "Mini Nutritional Assessment" (MNA) questionnaire and a scale that evaluates anorexia | Other | Patients with colorectal surgery |
| Evaluation of physical performanceThis will be assessed by using a "tiredness scale" named "Echelle Visuelle Analogique" (EVA) in french | Other | Patients with colorectal surgery |
| Evaluation of muscular strengthMuscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB) | Other | Patients with colorectal surgery |
| Evaluation of emotional statusThe emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS) | Other | Patients with colorectal surgery |
| Evaluation of functional statusThe functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire | Other | Patients with colorectal surgery |
Primary outcome
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.
4 secondary outcomes
activity of the ATGL
Time frame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Body composition
Time frame: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
metabolic phenotype
Time frame: 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
Time frame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy of adipose and muscular tissue, Blood sampling and Calorimetry in people with Colorectal Tumor, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biological and radiological markers (time frame: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.