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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

Tracking Information
First Submitted Date May 5, 2017
First Posted Date May 22, 2017
Last Update Posted Date May 22, 2017
Actual Study Start Date November 2, 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2017)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 19, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers
Official Title Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cachexia
  • Squamous Cell Carcinoma
  • Head and Neck Cancer
Intervention Procedure: Tumor removal
Surgery
Study Groups/Cohorts
  • 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.
    Intervention: Procedure: Tumor removal
  • Control group
    55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
    Intervention: Procedure: Tumor removal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2017)
60
Original Actual Enrollment Same as current
Actual Study Completion Date May 2017
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03162042
Other Study ID Numbers CHU-326
2015-A00833-46 ( Other Identifier: 2015-A00833-46 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Clermont-Ferrand
Verification Date May 2017