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

NCT04716764 | Unknown

• 1 other identifier: dAGEs
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Female

Outcome Measures

Primary Outcomes (19)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  15 months (Before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy)

Secondary Outcomes (12)

• Body weight (kg)

  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)

• Body composition (%)

  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)

Study Arms (2)

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. 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

Healthy (Control) participants

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

Interventions

3-Day Food Intake Record OTHER

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

Case Group; Healthy (Control) participants

Eligibility Criteria

• Age: 19 Years - 64 Years
• Gender Eligibility Details: Breast cancer occurs almost entirely in female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Clinical diagnosis of breast cancer for the first time, Non-metastatic, Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead
• Hacettepe University: collaborator
• Turkish Society of Medical Oncology: collaborator

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

RECRUITING

Related Publications (15)

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  BACKGROUND

• 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.

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• 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.

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  PMID: 17029646 BACKGROUND

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  PMID: 21875283 BACKGROUND

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  PMID: 12949370 BACKGROUND

• 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.

  PMID: 17039458 BACKGROUND

• 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.

  PMID: 20497781 BACKGROUND

• 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.

  PMID: 15186133 BACKGROUND

• 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.

  BACKGROUND

• Zujko ME, Witkowska AM. Antioxidant Potential and Polyphenol Content of Selected Food. International Journal of Food Properties.2011; 14(2): 300-308.

  BACKGROUND

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual serum samples taken from participants will be used.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Neslişah RAKICIOĞLU, PhD

CONTACT

+90 (312) 305 10 94; neslisah@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 20, 2021
• Study Start: March 3, 2020
• Primary Completion: April 30, 2021
• Study Completion: June 30, 2023
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

TU (1)