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IRCT20200313046756N1 IRCT 2020-03-28 Kerman University of Medical Sciences Vitamin D, Probiotics and Breast Cancer Effects of 4 months of 25 Hydroxy vitamin D3 supplementation and probiotics independently and concomitantly on some factors affecting cancer progression in patients with breast cancer undergoing surgery referred to Shahid Bahonar Hospital in Kerman. 2020-04-08 anticipated 88 Complete https://irct.ir/trial/46512 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients will be divided into four intervention groups by the factorial method. Randomization Method: Factorial Randomization Unit: Person Randomization Tool: Random Number Table, Blinding description: People will be kept blind. 1. Patients: Each patient will receive a label according to the random number table that will appear on the patient's drug box. Medicines do not differ in appearance, taste, odor. The patient consumes two capsules daily. 2. Physician: The analyzing team will give the medicine boxes to the physician, and the physician will provide the medication based on the random number table. 3 Breast Cancer. Intervention 1: Intervention group: Patients receiving vitamin D3 at a dose of 1000 IU daily as a single oral capsule, with food, and with a probiotic placebo capsule for 16 consecutive weeks from breast cancer diagnosis until surgery. Intervention 2: Intervention group: Patients who receive single probiotics capsule daily at 1 billion CFU before meals with a single vitamin D3 placebo capsule for at least 16 weeks from cancer diagnosis until surgery. Intervention 3: Intervention group: Patients receiving vitamin D3 at a dose of 1000 IU daily as a capsule, with food and probiotic capsules daily with 1 billion CFU for 16 consecutive weeks from breast cancer diagnosis until surgery. Intervention 4: Intervention group: Patients who receive one vitamin D3 placebo capsule with food and one probiotic placebo capsule daily before meals for 16 consecutive weeks from breast cancer diagnosis until surgery. Yes - There is a plan to make this available What will be shared: All data will be initially de-identified. 1. Demographic Data of Participants: These data will generally be included in a table in the article. 2. Main outcome data: The article will be appended to the article in charts and tables as well as in an Excel file. Secondary outcome data in the article will be attached to the article in graphs and tables as well as in an Excel file. When: Starting data access period six months after the results are published To whom: Data will be available only to researchers working in academic and scientific institutions approved by the Ministry of Health Conditions: The data will be available to researchers for further statistical analysis Where to obtain: Refer to the person responsible for the project's scientific accountability to access the data How to obtain: Applicants will submit a personal resume and the purpose of the data to the person responsible for the scientific accountability of the plan. The responsible person will be required to investigate the request within one week of sending the researcher information. Comments:
public Ali Asghar Tirgar
Shahid Bahonar Hospital, Qaraney Street, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 1223 5019 tirgar4@gmail.com Kerman University of Medical Sciences scientific Masoud Rezaei
َAlley 3, Shahab Street, Qaraney square
Kerman Iran (Islamic Republic of) 7616886988 +98 34 3222 1558 masoudrezaei082@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Women over 18 years with clinical stage II and III breast cancer diagnosis. Undergoing Neo-adjuvant Treatment and Surgery. 18 years no limit Female Age less than 18 years Stages I and IV of Breast Cancer BMI >30 Non-surgical advanced or metastatic cancers Cancer with a Basal-like Molecular Pattern Patients who have been taking vitamin D or probiotic supplements for the past three months. People with hyperparathyroidism or hypoparathyroidism active Kidney stones in the past six months Renal Failure (Creatinine> 190mmol / L) Hypercalcemia History of taking part in other intervention tests. Hormone therapy history. History of radiotherapy Recent use of estrogenic drugs such as birth control pills Chronic diarrhea or constipation (over 4 consecutive weeks) History of inflammatory bowel disease Celiac disease, chronic pancreatitis, history of colectomy and ileostomy History of gallstones Liver Failures Known cases of AIDS Continuous and long-term use of antibiotics, consumption of aluminum hydroxate History of Thiazide diuretics Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: Patients receiving vitamin D3 at a dose of 1000 IU daily as a single oral capsule, with food, and with a probiotic placebo capsule for 16 consecutive weeks from breast cancer diagnosis until surgery. Intervention group: Patients who receive single probiotics capsule daily at 1 billion CFU before meals with a single vitamin D3 placebo capsule for at least 16 weeks from cancer diagnosis until surgery Intervention group: Patients receiving vitamin D3 at a dose of 1000 IU daily as a capsule, with food and probiotic capsules daily with 1 billion CFU for 16 consecutive weeks from breast cancer diagnosis until surgery. Intervention group: Patients who receive one vitamin D3 placebo capsule with food and one probiotic placebo capsule daily before meals for 16 consecutive weeks from breast cancer diagnosis until surgery Measurement of Miller-Payne Grade Index on Residual Tumor Tissue. Timepoint: 4 months after intervention. Method of measurement: Microscopic examination. Residual Cancer Burden Score on residual tumor tissue. Timepoint: 4 months after intervention. Method of measurement: By http://www.mdanderson.org/breastcancer_RCB. Ki-67 nuclear protein as a biomarker of cell proliferation. Timepoint: َAt the beginning of the intervention, by Core needle biopsy and 4 months later (after surgery) on the residual tumor tissue. Method of measurement: Immunohistochemical staining. Serum IL-1 beta. Timepoint: On the first day of the intervention and 4 months after the intervention. Method of measurement: enzyme-linked immunosorbent assay(ٍELISA). Serum IL-6. Timepoint: On the first day of the intervention and 4 months after the intervention. Method of measurement: ELISA. Serum IL-10. Timepoint: On the first day of the intervention and 4 months after the intervention. Method of measurement: ELISA. Serum TNF alpha. Timepoint: On the first day of the intervention and 4 months after the intervention. Method of measurement: ELISA. Zist Takhmir Pharmaceutical Company Kerman University of Medical Sciences Zist Takhmir Pharmaceutical Company Approved 2020-03-10 Research Ethics Committee of Kerman University of Medical Sciences Beginning of Ibn Sina Street, First of Jihad Boulevard, Somayeh intersection (Tahmasb Abad) Kerman Kerman Iran (Islamic Republic of)