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

October 21, 2021 updated by: Nehal Ali Suliman, Assiut University

Prognostic Value of Serum Albumin and Total Protein in Survival of Cancer Cachectic Patients

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: samir shehata, professor doctor
  • Phone Number: 01222302375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the association between serum albumin and total protein with one year mortality in patients with cancer cachexia
Time Frame: baseline
to evaluate the association between serum albumin and total protein with one year mortality in patients with cancr cachexia
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the association between anthropometric measures and other laboratory findings with one year mortality in patients with cancer cachexia
Time Frame: baseline
to evaluate the association between anthropometric measures and other laboratory findings with one year mortality in patients with cancer cachexia
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2021

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (ACTUAL)

November 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cancer cachexia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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