Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers (MYOCACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03162042
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The main objective of our study was to determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers. Secondary objectives consisted in studying their influence on the occurrence of cachexia, bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.

Condition or disease Intervention/treatment
Cachexia Squamous Cell Carcinoma Head and Neck Cancer Procedure: Tumor removal

Detailed Description:

Myostatin and activin A, two members of the superfamily TGF-β, have been shown to play a role on skeletal muscle mass regulation. In Humans, high plasma concentrations of activin A were observed in cancer patients, especially in cachectic subpopulations, suggesting their involvement in the development of cachexia.

55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. The patients underwent a complete nutritional assessment and multiple samples : blood before and 7 days after surgery, skeletal muscle biopsies, tumor biopsies. Plasma concentrations of myostatin, activin and follistatin were measured before and after tumor removal surgery. Concentrations of myostatin, activin and follistatin were also measured in an incubation medium of a tumor biopsy. Activin A and follistatin plasma concentrations were significantly increased in the cancer group (320 vs. 203 pg/ml ; p <0.001) (3593 vs 2148 pg/ml ; p <0.001), while myostatin plasma concentration was significantly decreased in this group (1542 vs. 2100 pg/ml ; p = 0.010). Surprisingly, data of the 7th postoperative day showed an increase in plasma activin A concentration (379 vs 320 pg /ml ; p <0.001) while concentrations of myostatin and follistatin were not modified. A high postoperative systemic inflammation is one hypothesis to explain these later results. Myostatin, activin A and follistatin proteins were systematically detected in the medium of tumor a 48 hour-incubation period, providing a strong proof of the tumor production of these factors by squamous cell carcinoma. The activin A/myostatin/follistatin is modified in the context of head and neck cancer. Activin A particularly seems to play a role in the occurrence of cachexia while follistatin could have a protective role for skeletal muscle mass. This system could aimed in therapeutic ways to reduce cachexia in a context of cancer in order to improve the quality of life and survival of patients.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : May 2017
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Squamous cell carcinoma
55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
 Procedure: Tumor removal
Surgery
Control group
55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
 Procedure: Tumor removal
Surgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Measure of plasma activin A (pg/ml) [ Time Frame: at day 1 ]
    determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers

  2. Measure of plasma follistation (pg/ml) [ Time Frame: at day 1 ]
    determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers

  3. Measure of plasma myostatin (pg/ml) [ Time Frame: at day 1 ]
    determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers


Secondary Outcome Measures :
  1. Influence on the occurrence of cachexia [ Time Frame: at day 1 ]
    Bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
Criteria

Inclusion Criteria:

For case group :

  • head and neck cancer
  • squamous cell carinoma only
  • head and neck surgery chosen as treatment of cancer
  • age 18-75

For control group :

  • Neck surgery for non oncologic disease
  • age 18-75

Exclusion Criteria:

  • heart failure, respiratory failure (requiring a long-term oxygen therapy), chronic renal failure (MDRD clearance < 60 ml/min), moderate or severe chronic obstructive pulmonary disease and insulin-dependent diabeta for the two groups
  • cachexia for control group
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162042


Locations
Layout table for location information
France
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03162042    
Other Study ID Numbers: CHU-326
2015-A00833-46 ( Other Identifier: 2015-A00833-46 )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Activin A
Myostatin
Follistatin
Cachexia
Squamous cell carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Wasting Syndrome
Cachexia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders