Role of Serum Albumin and Total Protein in Survival of Cancer Cachectic Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05103059
Collaborator
(none)
100
13

Study Details

Study Description

Brief Summary

Serum albumin can indicate the onset of cancer cachexia, provide information about a patient's nutritional status, and serve as a biomarker for the prognosis of patients with cancer cachexia. However, the relationship between serum albumin levels and mortality in patients with cancer cachexia remains unclear. We aimed to examine the association of albumin and total protein with 1-year mortality in patients with cancer cachexia

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: BMI

Detailed Description

Cancer cachexia is defined as a multifactorial and multi-organ syndrome characterized by the loss of skeletal muscle mass (with or without loss of adipose tissue), which cannot be fully reversed by conventional nutritional support. In recent years, cancer cachexia has increasingly been seen as a systemic phenomenon that affects various organs, such as the liver and myocardial tissue. Cachexia is closely related to anorexia, inflammation, insulin resistance, and decreased protein levels, which can lead to progressive functional impairment, treatment-related complications, poor quality of life, and cancer-related death. Its pathophysiology is characterized by a negative protein and energy balance. However, there are no clear clinical guidelines to effectively combat the progressive tissue loss associated with cachexia. Cancer cachexia occurs mostly in advanced cancers, with more than half of patients with cancer having cachexia in the later stages, and >10% of patients die with or from it.

Studies have shown that cachexia can be diagnosed when weight loss in the past 12 months is ≥5%, and the physiological variables of patients match at least threeof the following five criteria: decreased muscle strength,fatigue, anorexia, low fat-free mass index (FFMI), and abnormal blood profile. Albumin and total protein are two variables that reflect an individual's nutritional status and disease severity. Additionally, albumin can serve as an indicator of the inflammatory response and is considered a highly sensitive marker of a patient's nutritional status. Serum albumin and total protein can be used to define cancer cachexia and cancer-related malnutrition; patients with cachexia have lower total protein and albumin levels than those without cachexia.5 Serum albumin may serve as a prognostic factor for treatment outcomes and compliance in patients with advanced cancer.

Although a reduction in albumin and total protein levels are associated with the diagnosis of cancer related cachexia, no studies have shown that albumin and total protein can predict mortality in patients with cancer cachexia. Here, we describe a prospective non randomized study that will be conducted to explore the association between serum albumin and total protein levels and 1-year mortality in patients with cancer cachexia .

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prognostic Value of Serum Albumin and Total Protein in Survival of Cancer Cachectic Patients
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. the association between serum albumin and total protein with one year mortality in patients with cancer cachexia [baseline]

    to evaluate the association between serum albumin and total protein with one year mortality in patients with cancr cachexia

Secondary Outcome Measures

  1. the association between anthropometric measures and other laboratory findings with one year mortality in patients with cancer cachexia [baseline]

    to evaluate the association between anthropometric measures and other laboratory findings with one year mortality in patients with cancer cachexia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • patients who will accept to participate in our study with diagnosis of cancer cachexia
Exclusion Criteria:
  • patients who not fulfill criteria of cance cachexia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nehal Ali Suliman, prognostic value of serum albumin and total protein in survival of cancer cachectic patients, Assiut University
ClinicalTrials.gov Identifier:
NCT05103059
Other Study ID Numbers:
  • cancer cachexia
First Posted:
Nov 2, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2021