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IRCT20241015063367N1 IRCT 2024-12-16 Kerman University of Medical Sciences Investigating the effect of aspirin in breast cancer Comparison of the therapeutic effect of aspirin in combination with standard chemotherapy regimens compared to placebo in breast cancer 2024-10-22 anticipated 100 Complete https://irct.ir/trial/79604 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, all patients will receive standard neoadjuvant chemotherapy regimens based on the prescription of a hemato-oncology specialist. Chemotherapy regimens will include regimens based on cyclophosphamide, adriamycin, and taxols. Participants who meet the inclusion and exclusion criteria of the study will be randomly assigned 1:1 to receive aspirin or placebo during their neoadjuvant chemotherapy treatment after obtaining informed consent and explaining the research objectives. Randomization will be performed using a computerized randomization sequence. Patients in the intervention group will be treated with aspirin 100 mg daily during the period of neoadjuvant chemotherapy. Patients in the control group are similarly receiving placebo daily during the period of neoadjuvant chemotherapy. The placebo will be delivered to the patients in the control group in capsules with the same appearance as aspirin but without the effective pharmacological substance. The distribution of patients in the two groups is similar in terms of disease stage and hormone receptor, Blinding description: This study will follow a triple blind design. In this way, neither the participants, nor the researchers involved in data collection, nor the statistical analyst of the project will be aware of the group to which the patients have been assigned. Aspirin and placebo capsules will look identical. A third party not involved in the measurement of outcomes and analysis of results will be responsible for labeling the study drugs according to the randomized sequence and maintaining the blinding process of the study until the end of the data analysis. Unblinding will only be done if a medical emergency occurs during the study for the patient that requires knowledge of the prescribed treatment, in which case the patient will be excluded from the study. 3 Breast cancer. Intervention 1: Intervention group: after obtaining informed consent and explaining the objectives of the research, aspirin 81 milligrams daily is given to the intervention group. Intervention 2: Control group: A placebo is given to the control group. Yes - There is a plan to make this available What will be shared: On website When: After publishing To whom: Every one Conditions: For searching, treatment Where to obtain: Internet Email roghayeabdollahi@yahoo.com How to obtain: After searching on internet it is accessible Comments:
public Roghaye Abdollahi
Imam Highway, Afzalipur Hospital
Kerman Iran (Islamic Republic of) ۷۶۱۶۹۱۳۳۵۵ +98 34 3132 8000 roghayeabdollahi@yahoo.com Kerman University of Medical Sciences scientific Maryam Bahador
Emam Khomeini
Kerman Iran (Islamic Republic of) ۷۶۱۶۹۱۳۳۵۵ +98 34 3132 8000 maryamb2003@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) 1. Women aged 18 to 70 with breast cancer who have been confirmed by histopathological diagnosis 2. Stage II to III who are candidates for neoadjuvant chemotherapy 3. Zero or on Eastern Cooperative Oncology Groupperformance index 4. Informed consent to enter the study 18 years 70 years Female 1. Patients with a history of other malignancies, a history of myocardial infarction, a history of atrial fibrillation, and a history of grade hypertension 2. Contraindications of aspirin use 3. Simultaneous use of warfarin, heparin or heparin analogues, clopidogrel, thrombin inhibitors or coagulation factors 4. History of taking aspirin within 30 days before entering the study C50 Malignant neoplasm of breast Treatment - Other Placebo Intervention group: after obtaining informed consent and explaining the objectives of the research, aspirin 81 milligrams daily is given to the intervention group Control group: A placebo is given to the control group Complete pathologic response. Timepoint: 4 month. Method of measurement: Pathology report. Kerman University of Medical Sciences Approved 2024-09-23 Ethics committee of kerman University of Medical Sciences Emam khomeini Kerman Kerman Iran (Islamic Republic of)