- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131478
Effect of Gene Polymorphisms on the Pathogenesis of Cancer Cachexia
Relationship Between TNF Alpha Gene Polymorphisms and the Pathogenesis of Cachexia in Cancer Patients Treated With Chemotherapy
Cachexia not only directly increases the morbidity and mortality, it also aggravates the side effects of chemotherapy and reduces the overall quality of life that is often considered the major and direct cause of morbidity of a large proportion (>40%) of cancer patients. Individuals with upper gastrointestinal tumors have the highest rate of developing cachexia associated complications. Chemical and physical signals render an environment conducive for disuse and untenable for proper muscle function leading to wasting.
Till now, several functional single-nucleotide polymorphisms (SNPs) within TNF-α gene have been identified and described as cancer related genetic alterations.
Study Overview
Detailed Description
Cachexia is a devastating syndrome that is observed in the majority of end stage cancer patients. Primary symptoms of cancer cachexia comprise of progressive loss in weight and exhaustion of host skeletal muscle tissue as well as adipose tissue reserves.
Cancer cachexia is defined as a multifactorial syndrome, characterized by anorexia as well as diminished body weight, loss of skeletal muscle, and atrophy of adipose tissue (Fearon et al., 2011). Specifically, weight loss of more than 5% over 6 months span in previously healthy individuals or more than 2% in subjects with depletion of current body weight (BMI less than 20 kg/m2) or in individuals with reduced appendicular muscle index (males less than 7.26 kg/m2 and females less than 5.45 kg/m2) constitute the diagnosis of cancer cachexia.
Among potential mechanisms involved in the development of cachexia, the primary initial process is probably the systemic inflammatory response followed by increased production of pro-inflammatory cytokines, such as TNF-α. Multiple biological activities of TNF-α were found in numerous physiological states, including the regulation of cell differentiation, proliferation, apoptosis and metabolism .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rana M. Yehia, MSc
- Phone Number: +201006666652
- Email: rana.magdy@miuegypt.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 11314
- Recruiting
- Ain Shams University Hospitals
-
Contact:
- Dr. Amr Shafik, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with medical diagnosis of cancer (eg, lung, pancreas, gastric, biliary, small intestine, or colorectal) Locally, advanced or metastatic cancer scheduled for the first line cytotoxic chemotherapy were eligible for inclusion. Patients who were starting or continuing chemotherapy at the time of screening for participants
- The duration was set based on standard period of first line chemotherapy
- Age of 18 years to 80 years
- Written informed consent of the subject to participate in the study
Exclusion Criteria:
- Planned to have surgical procedures at the time of recruitment
- Underwent surgery during the study or in the month prior to the study and did not have chemotherapy scheduled postsurgery
- Had any comorbidities that could affect the interpretation of study findings (eg, HIV, AIDS, Alzheimer's disease, movement disorder, acute myocardial infarction within last 3 months, hepatitis)
- Had open burn sites or infected wounds
- Were diagnosed with esophageal cancer with a swallowing difficulty in mechanical nature
- Had an uncorrected, mechanical digestive obstruction
- Pregnant or nursing women
- Disorders associated with change in micro RNA (miR-155) level (Rheumatic Arthritis, Osteoarthritis, Atopic Eczema, Down Syndrome, Breast cancer, Endometrioid adenocarcinoma, AML, CLL, PC thyroid tumors)
- Inflammatory and autoimmune diseases (Multiple Sclerosis, Psoriasis and Systemic Lupus Erythematous)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cases
Cachectic lung, pancreas, or colon cancer patients.
|
Pharmacogenetic testing for TNF alfa
|
Control
Non- cachectic lung, pancreas, or colon cancer patients.
|
Pharmacogenetic testing for TNF alfa
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TNF-α -1031T/C and 308 G/A
Time Frame: 6 months
|
To detect the incidence of tumor necrosis factor (TNF-α -1031T/C and 308 G/A) gene polymorphism in the Egyptian cancer patients with local/advanced or metastatic cancer and investigation of TNF-α -1031T/C and 308 G/A as a cachexia risk factor.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical markers
Time Frame: 6 months
|
SOCS1, TAB2 and FOXP3
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT (2387)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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