Clinical trial NCT03477721: The Role of the Muscle-nervous System Interface in Cancer Cachexia
Official title: The Role of the Muscle-nervous System Interface in Cancer Cachexia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cachexia; Cancer; Sarcopenia
Keywords: Agrin Fragment C-terminus (CAF)
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oure sample will be selected between cancer patient of Rome Umberto I Hospital

Brief summary: Sarcopenia is an important component of cachexia associated with cancer, and their high incidence in cancer patients emphasizes the need for a better understanding of its mechanisms, which can result in better therapeutic interventions to reverse this situation and improve the prognosis. Our hypothesis is that the plasma concentration of IL-6 and c-terminal agrin is directly correlated with the loss of muscle mass and development of cachexia.

Detailed description: The agrin is a protein that acts on neuromuscular junctions (NMJs) promoting stabilization of same, which results in the maintenance and growth of muscle fibers, but the cleavage of agrin, a process by which is formed the agrin fragment C-terminus (CAF), has been linked to the development of sarcopenia, because its presence is directly linked to the reduction in the number of muscle fibers, increasing the heterogeneity of fiber size, presence of Central cores and increasing the proportion of type I fibers and consequently a greater degradation of lean body mass. Studies in mice show that the greatest cleavage of agrin carries on development of sarcopenia and human studies report that individuals with higher serum levels of sarcopenia CAF compared to individuals without sarcopenia.

Therefore, aiming at the complexity of cancer associated with the cachexia and the great importance of the maintenance of lean body mass to a better prognosis in disease, is of fundamental importance to elucidate the role of CAF and the factors associated with sarcopenia, the possible use of these proteins for diagnosis and the contribution that this clarification could bring in clinical therapy.

Eligibility criteria: Inclusion Criteria:

* cancer diagnosis

Exclusion Criteria:

* continuously use of anti-inflammatory medications;
* present renal and/or liver failure,
* AIDS,
* inflammatory bowel disease or chronic inflammatory processes not related to cachexia.

Primary outcomes:
measure: Agrin fragment c-terminus CAF in cancer and cancer cachexia
timeFrame: 1 month
measure: Agrin fragment c-terminus CAF in cancer sarcopenia
timeFrame: 1 month
measure: Agrin fragment c-terminus CAF and IL-6 levels
timeFrame: 1 month
measure: Agrin fragment c-terminus (CAF) and IL-6 and lean body mass
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Clinical Medicine, Sapienza University of Rome
Study officials:
affiliation: Department of Clinical Medicine, Sapienza University of Rome, Italy
name: Alessandro Laviano, MD
role: PRINCIPAL_INVESTIGATOR
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