Breast Cancer.
Conditions
Interventions
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 bre
Sponsors
Kerman University of Medical Sciences
Zist Takhmir Pharmaceutical Company
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women over 18 years with clinical stage II and III breast cancer diagnosis. Undergoing Neo-adjuvant Treatment and Surgery.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Asghar Tirgar
Kerman University of Medical Sciences
Outcome results
None listed