An observational study in Breast Cancer and Female, sponsored by Necmettin Erbakan University. Status unknown at 1 site in Turkey. Open to female participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Necmettin Erbakan University · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 32 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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Case group: The study will include female individuals aged 19-64 years who applied to Necmettin Erbakan University Meram Medical Faculty General Surgery and Medical Oncology Departments and were diagnosed with breast cancer for the first time and volunteering to participate in the study.
Control group: The control group consists of healthy adult women who applied to the Internal Diseases (Internal Medicine) outpatient clinic of Necmettin Erbakan University Meram Medical Faculty Hospital, who are at the same age as the case group, and who have not been diagnosed with any disease by the doctor, and who are willing to participate in the study.
Clinical diagnosis of breast cancer for the first time, Non-metastatic, Written informed consent
Exclusion Criteria:
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
The study will include female individuals aged 19-64 years who applied to Necmettin Erbakan University Meram Medical Faculty General Surgery and Medical Oncology Departments and were diagnosed with breast cancer for the first time and volunteering to participate in the study. Patients with breast cancer will be followed up before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy.
Other: 3-Day Food Intake Record
The control group consists of healthy adult women who applied to the Internal Diseases (Internal Medicine) outpatient clinic of Necmettin Erbakan University Meram Medical Faculty Hospital, who are at the same age as the case group, and who have not been diagnosed with any disease by the doctor, and who are willing to participate in the study. Healthy individuals will be interviewed once. The obtained data will be compared with the preoperative data of breast cancer patients.
Other: 3-Day Food Intake Record
Collecting clinical and socio-demographic information, nutritional status, food consumption (dietary intake of advanced glycation end products, dietary total antioxidant capacity, dietary inflammatory index), anthropometric measurements (body weight, height, body composition, handgrip strength, upper-middle arm circumference, waist circumference, hip circumference, triceps skinfold thickness), quality of life, biochemical biomarkers (serum carboxymethyl lysine, advanced glycation end products receptor, the soluble receptor of advanced glycation end products, TNF-α, IL-1β, IL-6, malondialdehyde, 2,4-dinitrophenyl hydrazine, 8-hydroxy-2'-deoxyguanosine, total antioxidant capacity)
Also known as: Anthropometric Measurements, Serum Advanced Glycation End Products Biomarkers
Dietary Advanced Glycation End Products Intake (kilounit/day)
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.
Time frame: 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)
Serum carboxy methyl lysine (CML) level (pg/mL)
It will be determined with ELISA.
Time frame: 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)
Serum receptor for advanced glycation end products (RAGE) level (pg/mL)
It will be determined with ELISA.
Time frame: 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)
Serum soluable receptor for advanced glycation end products (sRAGE) level (pg/mL)
It will be determined with ELISA.
Time frame: 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)
Serum tumor necrosis factor alfa (TNF-α) level (pg/mL)
Tumor necrosis factor alfa (TNF-α) will be determined with ELISA.
Time frame: 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)
Serum interleukin 1 beta (IL-1β) level (pg/mL)
Interleukin 1 beta (IL-1β) will be determined with ELISA.
Time frame: 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)
Serum interleukin 6 (IL-6) level (pg/mL)
Interleukin 6 (IL-6) will be determined with ELISA.
Time frame: 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)
Serum lipid peroxidation level: Malondialdehyde (nmol/mL)
Malondialdehyde will be determined with ELISA.
Time frame: 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)
Serum protein oxidation level:2,4-Dinitrophenylhydrazine (nmol/mL)
2,4-Dinitrophenylhydrazine will be determined with ELISA.
Time frame: 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)
Serum DNA damage level: 8-hydroxy 2 deoxyguanosine(ng/mL)
8-hydroxy 2 deoxyguanosine will be determined with ELISA.
Time frame: 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)
Serum total antioxidant capacity (μmol/L)
It will be determined with spectrophotometric assay.
Time frame: 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)
Dietary total antioxidant capacity: Total Oxygen Radical Absorbans Capacity (T-ORAC) (µmol Trolox equivalent)
It is calculated by using tables published in previous articles.
Time frame: 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)
Dietary total antioxidant capacity: Lipophilic Oxygen Radical Absorption Capacity (L-ORAC)(µmol Trolox equivalent)
It is calculated by using tables published in previous articles.
Time frame: 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)
Dietary total antioxidant capacity: Hydrophilic Oxygen Radical Absorption Capacity (L-ORAC)(µmol Trolox equivalent)
It is calculated by using tables published in previous articles.
Time frame: 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)
Dietary total antioxidant capacity:Trolox Equivalent Antioxidant Capacity (TEAC) (mmol Trolox equivalent)
It is calculated by using tables published in previous articles.
Time frame: 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)
Dietary total antioxidant capacity:Total Radical Trapping Antioxidant Parameter (TRAP) (mmol Trolox equivalent)
It is calculated by using tables published in previous articles.
Time frame: 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)
Dietary total antioxidant capacity:Ferric Reducing Antioxidant Potential (FRAP)(mmol)
It is calculated by using tables published in previous articles.
Time frame: 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)
Dietary inflammatory index (score)
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.
Time frame: 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)
Nutritional status
The malnutrition status and severity of participants with breast cancer are determined with Patient Generated Subjective Global Assessment (PG-SGA) test.
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Body weight (kg)
Body weight is measured in lightly dressed clothing without shoes by using an electronic scale sensitive to 100 g.
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Height (cm)
Height is measured using stadiometer in the position of Frankfort plane without shoes.
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Body mass index (kg/m2)
Body mass index (BMI) is calculated by dividing body weight in kilograms by height in metres squared.
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Body composition (%)
The percentages of body fat, body water and lean body mass are measured through bioelectrical impedance analysis.
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Handgrip strength (kg)
Handgrip strength is measured using a handgrip dynamometer.
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Mid-upper arm circumference (cm)
Mid-Upper Arm Circumference (MUAC) is the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow (olecranon process and the acromium).
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Triceps skinfold thickness (mm)
The triceps skinfold is measured at the back of the left arm, midway between the acromial process of the scapula and the olecranon process of the ulna.
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Waist circumference (cm
Waist circumference is measured at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest
Time frame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Hip circumference (cm)
Hip circumference is measured around the widest portion of the buttocks.
Time frame: 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)
The quality of life of women with breast cancer is evaluated with the European Cancer Research and Treatment Organization Quality of Life Scale - Cancer 30 (EORTC QLQ-C30). It consists of 30 items to assess physical, role, emotional, cognitive and social functioning, global health status or qualitiy of life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. Items are measured using a 4-point Likert Scale ranging from Not at all (1) to Very much (4). The lowest score obtained from the scale is 0, the highest score is 100. Higher scores represent higher general health and functional scores and higher scores indicate higher symptom severity.
Time frame: 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 )
The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss. Items measured using 4-point Likert Scale ranging from Not at all (1) to Very much (4). The lowest score obtained from the scale is 0, the highest score is 100. Higher scores represent higher functional scores and higher scores indicate higher symptom severity.
Time frame: 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 )
Short-Form 36-Item Health Survey questionnaire is used to determine the quality of life levels of healthy women.The questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). A final item, termed self-reported health transition, is answered by the client but is not included in the scoring process. The SF-36 offers a choice of recall format at a standard (4 week) or acute (1 week) time frame. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire. Obtained score ranges from 0 to 100. Higher scores indicate better health status.
Time frame: 3 months
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