Mitochondrial Activity and Myosteatosis in the Cachexia of Cancers of the Upper Aerodigestive Tract

NCT03111771 | Unknown

• 2 other identifiers: CHU-3132016-A00611-50
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Loss of muscle mass (scientific term: cachexia) affects about 80% of patients with advanced cancer and impacts their prognosis by decreasing tolerance and response to treatment, decreasing quality of life and survival. The prognosis in these patients depends directly on the importance of the loss of muscle mass. Preserving it is therefore an essential therapeutic objective. It is therefore important to understand perfectly the mechanism of this muscular loss. The accumulation of fat in the muscle (scientific term: myosteatosis) could be a mechanism responsible for this loss of muscle mass. It is indeed a hypothesis proved on animal models. Moreover, it has recently been shown that more the cancer patient loses weight, more his muscle contains fat. This lets think that this deposit of fat in the muscle would be directly related to the loss of muscle mass. All of these observations could not be clearly established in humans and investigators are seeking by this study to illuminate these mechanisms at the human level. A better understanding of these mechanisms would allow investigator to set up targeted treatments against the accumulation of fat in the muscle, which would significantly improve the quality of life of patients with cancer of the aerodigestive pathways and their chances of recovery. The MYOMEC study includes the inclusion of healthy patients (to form a control group) but also patients with cancer of the upper aero-digestive tract. The study will be divided into two parts: clinical examination and nutritional evaluation the day before surgery at the time of the participants' admission to hospital and then the biological samples during surgery. The nutritional examination consists in collecting the morphological data of the patient, namely: Its weight, size, calculation of the body mass index Tests of muscular strength (wearing weight of 1, 2 and 3 kilos) Measurement of the percentage of fat mass and lean mass (Impedancemetry) In this study, participants benefit from the following investigations:

• Clinical examination complete with elaboration of the clinical nutritional status, realized the day before the surgical intervention in hospitalization.
• Elaboration of the radiological nutritional status by a complementary analysis of the scanner envisaged in the balance of extension of the disease
• Performing surgical site sampling during surgery without additional invasive procedure and under general anesthesia. It will be realized: A muscle biopsy of the sterno-cleido-mastoid muscle (neck muscle) (maximum volume 5 mm3), A tumor biopsy (maximum volume 5mm3). A blood sample (maximum volume 5ml) No invasive procedure, supplemental examination or additional consultation is required for the whole off-set study for the extensive muscular percutaneous biopsy regarding which additional patient agreement will be required. No additional follow-up is required when participating in this study. Participation in this study does not entail any particular constraint or additional treatment. The duration of the patient's participation is defined as follows: from the date of the preoperative consultation or from the consultation of announcement until his / her discharge from hospital. The exclusion period defined in this study extends from the date of inclusion of the patient to the date of the surgical procedure, during which time the patient can not participate in another clinical research protocol.

Conditions

Cancer of Upper Aerodigestive Pathways; Cachexia

Keywords

Cancer; Cachexia; Myosteatosis; Mitochondrial activity; Upper aerodigestive pathways; Lipotoxicity

Outcome Measures

Primary Outcomes (1)

• ATP / Oxygen ratio

  The ratio of ATP produced by mitochondria and oxygen consumed by muscle mitochondria

  at day 1

Secondary Outcomes (9)

• Study of enzymatic mitochondrial activity

  at day 1

• Study of the activity of muscle lipases

  at day 1

• Study of the mobilization of the muscular lipid droplets

  at day 1

• Study of the muscular lipid infiltration

  at day 1

• Study of myosteatosis

  at day 1

Study Arms (3)

Group K +

Group K +: cancer of the upper aerodigestive tract with or without cachexia

Procedure: carcinological surgery

Group K-

Group K-: absence of cancer and absence of cachexia

Procedure: cervical surgery

Control group

The MYOMEC study includes the inclusion of healthy patients (to form a control group

Procedure: carcinological surgery; Procedure: cervical surgery

Interventions

carcinological surgery PROCEDURE

carcinological surgery for Group K +

Control group; Group K +

cervical surgery PROCEDURE

cervical surgery for Group K-

Control group; Group K-

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cancer of the upper aerodigestive tract

You may qualify if:

• For the Cancer Group (K + Group):
• Active cancer of the upper aerodigestive tract
• Eligible for surgery treatment decided by CPR
• Age ≥ 18 years or Age ≤ 80 years
• For the control Group (K- Group):
• No active cancer or a history of cancer less than 5 years old - Head and neck surgery for any reason except cancer
• Absence of cachexia, defined by a weight loss\> 5% over the last 6 months
• Age ≥ 18 years or Age ≤ 80 years

You may not qualify if:

• For groups K + and K-:
• Presence of another obvious etiology of undernutrition
• A history of heart failure, respiratory failure (requiring long-term oxygen therapy) or chronic renal disease (MDRD clearance \<60 ml / min), moderate, severe or very severe COPD (HAS classification), insulin-dependent diabetes , Coronary artery disease
• Age \<18 years or Age \>80 years
• Protected persons and pregnant and / or nursing women
• For the group K-:
• \- Posterior diagnosis of cancer in the case of anatomo-pathological analysis (eg thyroidectomy, parotidectomy)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Cachexia; Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Stéphane WALRAND

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 13, 2017
• Study Start: November 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

FR (1)