Dietary Advanced Glycation End Products, Inflammation and Oxidative Stress in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title: Evaluation of The Relationship Between Dietary Advanced Glycation End Products With Inflammation and Oxidative Stress in Breast Cancer Patients

Status Recruiting

Clinical Trial Summary

Breast cancer is among the most common types of cancer in the world. Factors such as age, reproduction, nutrition, hormonal, and lifestyle factors also play a role in the etiology of breast cancer. Nutrition can affect cancer metabolism at stages such as carcinogen metabolism, cell, and host defense, cell differentiation, and tumor growth. When investigating nutrition and breast cancer risk, it is important to evaluate the preparation and cooking processes applied to foods. Advanced glycation end products (AGE) are formed as a result of heat treatment applied to foods. There are studies showing that AGEs increase inflammation and oxidative stress in the organism. It is aimed to compare the dietary AGE intake and serum levels of AGE participants with breast cancer and healthy participants and to examine the relationship with serum inflammatory, oxidative stress, DNA damage, and total antioxidant capacity. Patients with breast cancer will be evaluated before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy. The amount the dietary AGE intake, serum markers, nutritional status, and changes in quality of life will be determined.

Clinical Trial Description

The Location of the Research: The research is carried out in Konya Necmettin Erbakan University Meram Faculty of Medicine General Surgery, Medical Oncology, and Biochemistry Departments. After obtaining the permission of the ethics committee, official permission was obtained from Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician to conduct the study.

The Sample Size of the Study: It was calculated by in G * Power 3.1.9.2 the computer program. It was determined by taking into account the mean and standard deviation of the blood advanced glycation end products level variable of previous (3.3 ± 1.2 × 105 arbitrary units (AU) in breast cancer patients, 2.3 ± 0.7 × 105 AU in healthy individuals). Considering that the number of samples in the control and breast cancer groups would be equal, it was determined that both groups should consist of at least 27 individuals with an error margin of d = 1.02, α = 0.05, and a power of 0.95. Considering that there will be losses in the sample, at least 32 individuals will be included in both groups. In this study, all of the patients participating in the research are informed in detail and informed consent forms are obtained from all participants.

Statistical analysis: The data will be assessed using the SPSS 22 statistical software package. Mean, standard deviation, minimum and maximum values of the quantitative data will be calculated, and the number and percentage tables of the qualitative data will be created.

In the comparison of quantitative data of the case group (before surgery) and control group, the Student t-test will be used for the normal distribution, and the Mann-Whitney U test will be used for the non-normal distribution. The chi-squared test will be used to evaluate qualitative data.

In the comparison of quantitative data of the case group during follow-up (before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy) one-way ANOVA will be used for the normal distribution, and the Friedman test will be used for the non-normal distribution.

While determining the correlation between quantitative data, the Pearson correlation coefficient will be used for normal distribution and the Spearman correlation coefficient will be used for non-normal distribution.

The p-value < 0.05 was considered to be statistically significant at the end of the analysis. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Female
• Inflammation

• NCT number: NCT04716764
• Study type: Observational
• Source: Necmettin Erbakan University
• Contact: Neslisah RAKICIOGLU, PhD
• Phone: +90 (312) 305 10 94
• Email: neslisah@hacettepe.edu.tr
• Status: Recruiting
• Start date: March 3, 2020
• Completion date: June 30, 2023