The Role of the Muscle-nervous System Interface in Cancer Cachexia

• Conditions: Cachexia; Cancer; Sarcopenia

• Registration Number: NCT03477721
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-11
• Study Start: 2018-03-16
• Study First Submitted QC: 2018-03-18
• Last Update Submitted: 2018-03-18
• Study First Posted: 2018-03-26
• Last Update Posted: 2018-03-26
• Primary Completion: 2018-04-16
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agrin fragment c-terminus CAF in cancer and cancer cachexia	1 month	To measure the contents of agrin fragment c-terminus (CAF) in plasma of patient with cancer and cancer cachexia.
Agrin fragment c-terminus (CAF) and IL-6 and lean body mass	1 month	To correlate levels of agrin fragment c-terminus (CAF) and IL-6 with the lean body mass
Agrin fragment c-terminus CAF and IL-6 levels	1 month	To correlate levels of agrin fragment c-terminus (CAF) and IL-6 plasma levels in patients with cancer and with cancer cachexia.
Agrin fragment c-terminus CAF in cancer sarcopenia	1 month	To analyze correlation between Agrin fragment c-terminus CAF and the lean body mass (CT-scan estimated) of patients with cancer and with cancer cachexia.

Trial Locations

Locations (1)

Department of Clinical Medicine, Sapienza University of Rome; 🇮🇹 Rome, Italy