Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy

NCT02830620 | Completed

• 1 other identifier: 12-PP-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The syndrome of anorexia-cachexie, which accompanies numerous cancers is a major comorbidity which compromises the forecast of these patients. Several cytokines pro-inflammatory as interleukines IL1 ß, IL6 or TNFa participate in the physiopathology of this syndrome at the man and the animal. Besides, it is now established that different neuronal populations, localized in the hypothalamus, are nerve centers of the control of the appetite and the energy homéostasie. However, there is not enough evidence of a direct action of cytokines on these neurones, suggesting the participation of intermediate molecules as chimiokines, inflammatory molecules produced in reaction to an immunological stress by gliales cells and acting directly on the surrounding neurones. The implication of chimiokines in the syndrome of anorexia-cachexie associated with the cancer thus seems very likely Among these, chimiokines " Monocyte Chemoattractant Proteins 1-3 " or MCPs represent obvious candidates because they are produced by multiple tumors. Furthermore, to the mouse, the intellectual expression of MCP1 is correlated in the anorexia led by peripheral injections of a bacterial by-product, the lipopolysaccharide (LPS). The investigators' main objective is to test at the Man's, in situation of cancer of the pancreas any confused stages, the degree of prédictivité of the chimiokine MCP1 towards the syndrome of anorexia-cachexie associated with the cancer. The investigator also suggest describing: i) the link between rate plasmatique of MCP1 and energy metabolism on one hand, physical composition on the other hand;; ii) the impact of the other chimiokines, particularly those of the family of the MCPs, on the anorexia-cachexie bound to the cancer, iii) the correlation enters their profile of expression plasmatique and the severity of the anorexia, the energy metabolism and the physical composition; iv) the same research on the other inflammatory factors plasmatiques, of nature different from chimiokines; v) the correlation between thin mass and anorexia; vi) the evolution of the chimiokines various and inflammatory factors after surgical treatment or chemotherapy with curative aim in 6 months.

Conditions

Cancer of the Pancreas; Anorexia

Outcome Measures

Primary Outcomes (1)

• chimiokine MCP1 expression

  Study at the Man's, in situation of cancer of the pancreas, diagnosed of novo and any confused stages, the prediction of the chimiokine MCP1 towards the syndrome of anorexia-cachexie associated with the cancer

  change from baseline to 180 days

Study Arms (4)

groupe1

OTHER

cancer of the pancreas WITH syndrome of anorexia-cachexie Dosage of chimiokines

Other: Dosage of chimiokines

groupe2

OTHER

cancer of the pancreas WITHOUT syndrome of anorexia-cachexie Dosage of chimiokines

Other: Dosage of chimiokines

groupe3

OTHER

pure food limitation typifies restrictive anorexia nervosa Dosage of chimiokines

Other: Dosage of chimiokines

groupe4

OTHER

unhurt individual of any appetite-suppressing evolutionary disease and cachectisante Dosage of chimiokines

Other: Dosage of chimiokines

Interventions

Dosage of chimiokines OTHER

groupe1; groupe2; groupe3; groupe4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient to hospitalize in the unit of digestive cancer research.
• Patient ≥ 18 years.
• Patient carrier of an adénocarcinome of the pancreas of novo, any stadium confused, diagnosed by imaging and/or histology.
• Existence of at least one of the criteria following to hold(retain) the diagnosis of cachexie cancer patient: not deliberate loss of weight \> in 5 % over the last 6 months OR(WHERE) IMC(CEREBRAL-MOTOR HANDICAPPED) \< 20 kg / m ² with a loss of minimum weight \> 2 % OR(WHERE) scrawny muscular index appendiculaire respectively \< 7,26 kg / m ² at the man and \< 5,45 kg / m ² at the woman with a minimal weight loss \> 2 %.
• Patient having signed the enlightened consent.

You may not qualify if:

• Patient having a tumor other one than the pancreatic adénocarcinome.
• Patient having a second offense of adénocarcinome pancreatic.
• Patient carrier of a pancreatic adénocarcinome in the course of a treatment by chemotherapy.
• Patient having a severe psychiatric comorbidity except TCA who can be responsible for food disorders.
• Patient carrier of an evolutionary inflammatory disease other one than the cancer being able to interfere on the inflammatory status.
• Groupe 2 {cancer du pancréas SANS syndrome d'anorexie-cachexie}
• Patient to hospitalize in the(unit) of digestive cancer research.
• Patient ≥ 18 years.
• Patient carrier of an adénocarcinome of the pancreas of novo, any stadium confused, diagnosed by imaging and/or histology.
• Patient having signed a enlightened consent.
• Patient having a tumor other one than the pancreatic adénocarcinome.
• Patient having a second offense(recurrence) of adénocarcinome pancreatic.
• Patient carrier of a pancreatic adénocarcinome in the course of a treatment by chemotherapy.
• Existence of at least one of the criteria in favour of the diagnosis of cachexie cancer patient: not deliberate loss of weight \> in 5 % over the last 6 months OR(WHERE) IMC(CEREBRAL-MOTOR HANDICAPPED) \< 20 kg / m ² with a loss of minimum weight \> 2 % OR(WHERE) scrawny muscular index appendiculaire respectively \< 7,26 kg / m ² at the man and \< 5,45 kg / m ² at the woman with a minimal weight loss \> 2 %.
• Patient having a severe psychiatric comorbidity except TCA who can be responsible for food disorders.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Anorexia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane SCHNEIDER, Pr

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 13, 2016
• Study Start: August 1, 2012
• Primary Completion: December 2, 2013
• Study Completion: December 24, 2019
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

FR (1)