跳至主要内容
临床试验/NCT03162042
NCT03162042已完成不适用

Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Measure of plasma myostatin (pg/ml)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Measure of plasma myostatin (pg/ml)

时间窗: 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)

时间窗: at day 1

determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers

Measure of plasma activin A (pg/ml)

时间窗: at day 1

determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers

次要结局

  • Influence on the occurrence of cachexia(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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