Clinical trial NCT04716764: Dietary Advanced Glycation End Products, Inflammation and Oxidative Stress in Breast Cancer Patients
Official title: Evaluation of The Relationship Between Dietary Advanced Glycation End Products With Inflammation and Oxidative Stress in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Female
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Turkish Society of Medical Oncology
First posted: 2021-01-20
Enrollment: 32
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Dietary Advanced Glycation End Products Intake (kilounit/day)
timeFrame: 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)
measure: Serum carboxy methyl lysine (CML) level (pg/mL)
timeFrame: 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)
measure: Serum receptor for advanced glycation end products (RAGE) level (pg/mL)
timeFrame: 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)
measure: Serum soluable receptor for advanced glycation end products (sRAGE) level (pg/mL)
timeFrame: 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)
measure: Serum tumor necrosis factor alfa (TNF-α) level (pg/mL)
timeFrame: 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)
measure: Serum interleukin 1 beta (IL-1β) level (pg/mL)
timeFrame: 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)
measure: Serum interleukin 6 (IL-6) level (pg/mL)
timeFrame: 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)
measure: Serum lipid peroxidation level: Malondialdehyde (nmol/mL)
timeFrame: 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)
measure: Serum protein oxidation level:2,4-Dinitrophenylhydrazine (nmol/mL)
timeFrame: 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)
measure: Serum DNA damage level: 8-hydroxy 2 deoxyguanosine(ng/mL)
timeFrame: 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)
measure: Serum total antioxidant capacity (μmol/L)
timeFrame: 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)
measure: Dietary total antioxidant capacity: Total Oxygen Radical Absorbans Capacity (T-ORAC) (µmol Trolox equivalent)
timeFrame: 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)
measure: Dietary total antioxidant capacity: Lipophilic Oxygen Radical Absorption Capacity (L-ORAC)(µmol Trolox equivalent)
timeFrame: 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)
measure: Dietary total antioxidant capacity: Hydrophilic Oxygen Radical Absorption Capacity (L-ORAC)(µmol Trolox equivalent)
timeFrame: 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)
measure: Dietary total antioxidant capacity:Trolox Equivalent Antioxidant Capacity (TEAC) (mmol Trolox equivalent)
timeFrame: 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)
measure: Dietary total antioxidant capacity:Total Radical Trapping Antioxidant Parameter (TRAP) (mmol Trolox equivalent)
timeFrame: 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)
measure: Dietary total antioxidant capacity:Ferric Reducing Antioxidant Potential (FRAP)(mmol)
timeFrame: 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)
measure: Dietary inflammatory index (score)
timeFrame: 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)
measure: Nutritional status
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
Secondary outcomes:
measure: Body weight (kg)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Height (cm)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Body mass index (kg/m2)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Body composition (%)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Handgrip strength (kg)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Mid-upper arm circumference (cm)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Triceps skinfold thickness (mm)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Waist circumference (cm
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Hip circumference (cm)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Quality of life score-Case group (European Cancer Research and Treatment Organization Quality of Life Scale - Cancer 30 (EORTC QLQ-C30)
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Quality of life score-Case group (the European Cancer Research and Treatment Organization Breast Cancer-Specific Quality of Life Scale )
timeFrame: 15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)
measure: Quality of life score-Control group (Short-Form 36-Item Health Survey )
timeFrame: 3 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Meram
Study officials:
References:
citation: Alpar R. Spor, sağlık ve eğitim bilimlerinden örneklerle uygulamalı istatistik ve geçerlik-güvenirlik. Ankara: Detay Yayıncılık; 2016.
citation: Tesarova P, Kalousova M, Jachymova M, Mestek O, Petruzelka L, Zima T. Receptor for advanced glycation end products (RAGE)--soluble form (sRAGE) and gene polymorphisms in patients with breast cancer. Cancer Invest. 2007 Dec;25(8):720-5. doi: 10.1080/07357900701560521.
citation: Shivappa N, Hebert JR, Rosato V, Montella M, Serraino D, La Vecchia C. Association between the dietary inflammatory index and breast cancer in a large Italian case-control study. Mol Nutr Food Res. 2017 Mar;61(3):10.1002/mnfr.201600500. doi: 10.1002/mnfr.201600500. Epub 2016 Nov 30.
citation: Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.
citation: Carlsen MH, Halvorsen BL, Holte K, Bohn SK, Dragland S, Sampson L, Willey C, Senoo H, Umezono Y, Sanada C, Barikmo I, Berhe N, Willett WC, Phillips KM, Jacobs DR Jr, Blomhoff R. The total antioxidant content of more than 3100 foods, beverages, spices, herbs and supplements used worldwide. Nutr J. 2010 Jan 22;9:3. doi: 10.1186/1475-2891-9-3.
citation: Demiral Y, Ergor G, Unal B, Semin S, Akvardar Y, Kivircik B, Alptekin K. Normative data and discriminative properties of short form 36 (SF-36) in Turkish urban population. BMC Public Health. 2006 Oct 9;6:247. doi: 10.1186/1471-2458-6-247.
citation: Demirci S, Eser E, Ozsaran Z, Tankisi D, Aras AB, Ozaydemir G, Anacak Y. Validation of the Turkish versions of EORTC QLQ-C30 and BR23 modules in breast cancer patients. Asian Pac J Cancer Prev. 2011;12(5):1283-7.
citation: Halvorsen BL, Carlsen MH, Phillips KM, Bohn SK, Holte K, Jacobs DR Jr, Blomhoff R. Content of redox-active compounds (ie, antioxidants) in foods consumed in the United States. Am J Clin Nutr. 2006 Jul;84(1):95-135. doi: 10.1093/ajcn/84.1.95.
citation: Pellegrini N, Serafini M, Colombi B, Del Rio D, Salvatore S, Bianchi M, Brighenti F. Total antioxidant capacity of plant foods, beverages and oils consumed in Italy assessed by three different in vitro assays. J Nutr. 2003 Sep;133(9):2812-9. doi: 10.1093/jn/133.9.2812.
citation: Pellegrini N, Serafini M, Salvatore S, Del Rio D, Bianchi M, Brighenti F. Total antioxidant capacity of spices, dried fruits, nuts, pulses, cereals and sweets consumed in Italy assessed by three different in vitro assays. Mol Nutr Food Res. 2006 Nov;50(11):1030-8. doi: 10.1002/mnfr.200600067.
citation: Uribarri J, Woodruff S, Goodman S, Cai W, Chen X, Pyzik R, Yong A, Striker GE, Vlassara H. Advanced glycation end products in foods and a practical guide to their reduction in the diet. J Am Diet Assoc. 2010 Jun;110(6):911-16.e12. doi: 10.1016/j.jada.2010.03.018.
citation: Wu X, Beecher GR, Holden JM, Haytowitz DB, Gebhardt SE, Prior RL. Lipophilic and hydrophilic antioxidant capacities of common foods in the United States. J Agric Food Chem. 2004 Jun 16;52(12):4026-37. doi: 10.1021/jf049696w.
citation: Wu X, Gu L, Holden J, Haytowitz DB, Gebhardt SE, Beecher G, Prior RL. Development of a database for total antioxidant capacity in foods: a preliminary study. Journal of Food Composition and Analysis.2004; 17(3): 407-422.
citation: Zujko ME, Witkowska AM. Antioxidant Potential and Polyphenol Content of Selected Food. International Journal of Food Properties.2011; 14(2): 300-308.
citation: Zujko ME, Witkowska AM. Antioxidant Potential and Polyphenol Content of Beverages, Chocolates, Nuts, and Seeds. International Journal of Food Properties. 2014; 17(1): 86-92.