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

Cachexia; Cancer; Sarcopenia Clinical Trial

— NUMANCAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03477721
• Other study ID #: NUMANCAN
• Status: Recruiting
• First received: March 11, 2018
• Last updated: March 18, 2018
• Start date: March 16, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: March 2018
• Source: University of Roma La Sapienza
• Contact: Laviano Alessandro
• Phone: +390649973902
• Email: alessandro.laviano[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2018
• Est. primary completion date: April 16, 2018
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Cachexia; Cancer; Sarcopenia
• Sarcopenia

Locations

Country	Name	City	State
Italy	Department of Clinical Medicine, Sapienza University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agrin fragment c-terminus CAF in cancer and cancer cachexia	To measure the contents of agrin fragment c-terminus (CAF) in plasma of patient with cancer and cancer cachexia.	1 month
Primary	Agrin fragment c-terminus CAF in cancer sarcopenia	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.	1 month
Primary	Agrin fragment c-terminus CAF and IL-6 levels	To correlate levels of agrin fragment c-terminus (CAF) and IL-6 plasma levels in patients with cancer and with cancer cachexia.	1 month
Primary	Agrin fragment c-terminus (CAF) and IL-6 and lean body mass	To correlate levels of agrin fragment c-terminus (CAF) and IL-6 with the lean body mass	1 month