Evaluation of The Relationship Between Dietary Advanced Glycation End Products With Inflammation and Oxidative Stress in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Serum tumor necrosis factor alfa (TNF-α) level (pg/mL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of breast cancer for the first time, Non-metastatic, Written informed consent
排除标准
- •Age < 19 years and > 64 years, Metastatic, Pregnancy, Lactation, Clinical diagnosis of moderate/severe neurological impairment, Clinical diagnosis of moderate/severe cognitive impairment, Clinical diagnosis of type 1 diabetes mellitus, Clinical diagnosis of type 2 diabetes mellitus, Refusal to participate
结局指标
主要结局
Serum tumor necrosis factor alfa (TNF-α) level (pg/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
Tumor necrosis factor alfa (TNF-α) will be determined with ELISA.
Serum interleukin 1 beta (IL-1β) level (pg/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
Interleukin 1 beta (IL-1β) will be determined with ELISA.
Serum DNA damage level: 8-hydroxy 2 deoxyguanosine(ng/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
8-hydroxy 2 deoxyguanosine will be determined with ELISA.
Dietary total antioxidant capacity:Ferric Reducing Antioxidant Potential (FRAP)(mmol)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It is calculated by using tables published in previous articles.
Serum carboxy methyl lysine (CML) level (pg/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It will be determined with ELISA.
Serum interleukin 6 (IL-6) level (pg/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
Interleukin 6 (IL-6) will be determined with ELISA.
Serum total antioxidant capacity (μmol/L)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It will be determined with spectrophotometric assay.
Nutritional status
时间窗: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
The malnutrition status and severity of participants with breast cancer are determined with Patient Generated Subjective Global Assessment (PG-SGA) test.
Dietary Advanced Glycation End Products Intake (kilounit/day)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
The amount of dietary carboxy methyl lysine intake is calculated using daily food consumption. Previous studies will be used for the carboxy methyl lysine content of foods.
Serum receptor for advanced glycation end products (RAGE) level (pg/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It will be determined with ELISA.
Dietary total antioxidant capacity:Total Radical Trapping Antioxidant Parameter (TRAP) (mmol Trolox equivalent)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It is calculated by using tables published in previous articles.
Serum soluable receptor for advanced glycation end products (sRAGE) level (pg/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It will be determined with ELISA.
Serum lipid peroxidation level: Malondialdehyde (nmol/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
Malondialdehyde will be determined with ELISA.
Dietary total antioxidant capacity: Lipophilic Oxygen Radical Absorption Capacity (L-ORAC)(µmol Trolox equivalent)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It is calculated by using tables published in previous articles.
Dietary total antioxidant capacity: Hydrophilic Oxygen Radical Absorption Capacity (L-ORAC)(µmol Trolox equivalent)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It is calculated by using tables published in previous articles.
Serum protein oxidation level:2,4-Dinitrophenylhydrazine (nmol/mL)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
2,4-Dinitrophenylhydrazine will be determined with ELISA.
Dietary total antioxidant capacity: Total Oxygen Radical Absorbans Capacity (T-ORAC) (µmol Trolox equivalent)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It is calculated by using tables published in previous articles.
Dietary total antioxidant capacity:Trolox Equivalent Antioxidant Capacity (TEAC) (mmol Trolox equivalent)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
It is calculated by using tables published in previous articles.
Dietary inflammatory index (score)
时间窗: 15 months (Case group:before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy, For control group: When healthy participant comes to the internal medicine clinic for a routine examination)
The inflammatory load value will be calculated by using energy, carbohydrate, protein, total fat, cholesterol, saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, n-3 and n-6 polyunsaturated fatty acids, vitamins (vitamin B12, B9, B6, B3, B2, B1, A, C, D and E) micronutrients (iron, zinc, selenium, magnesium), caffeine, tea, garlic, onion, pepper and β-carotene intake. The resulting value for each dietary factor was multiplied by the inflammatory score of each item to achieve the dietary factor dietary inflammatory index score. Then, all dietary factor dietary inflammatory index scores were summed to calculate the DII score for each participant.
次要结局
- Mid-upper arm circumference (cm)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Waist circumference (cm(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Body composition (%)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Triceps skinfold thickness (mm)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Hip circumference (cm)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Height (cm)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Body mass index (kg/m2)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Quality of life score-Case group (the European Cancer Research and Treatment Organization Breast Cancer-Specific Quality of Life Scale )(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Body weight (kg)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Handgrip strength (kg)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Quality of life score-Case group (European Cancer Research and Treatment Organization Quality of Life Scale - Cancer 30 (EORTC QLQ-C30)(15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy))
- Quality of life score-Control group (Short-Form 36-Item Health Survey )(3 months)
研究者
Şenay Burçin Alkan
Lecturer
Necmettin Erbakan University