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IRCT20180722040556N7 IRCT 2021-06-23 Esfahan University of Medical Sciences Omega 3 in the management of breast cancer patients Omega 3 in the management of menopausal complication due to hormonal therapy in breast cancer patients 2021-06-22 anticipated 60 Complete https://irct.ir/trial/50502 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The pockets containing medications (omega3 and placebo) will be coded, and each code will be written on the specific card. Thereafter, the eligible patient will be assigned to each group, randomly by selecting among shuffling cards. So, the allocation sequence will be concealed until the moment of assignment, and nobody knows what is the next treatment allocation. It should be mentioned that participants, health care providers, assessors, and data collector unaware of the assigned intervention (allocated codes), Blinding description: For keeping participants, investigators, and health care providers will be kept blind, whole omega 3 tablets will be extracted from blister and separated into 60-tablets considered packages by the main investigator. Finally, all drugs and placebo packages will be labeled by codes extracted from internet-based software. After completion of recruitment, each patient's code was coordinated with software data, and the investigator or health care providers will be informed after data analyses of drugs' codes. 3 Breast cancer. Intervention 1: Intervention group: Omega 3 capsules 2 g daily (twice a day orally) for 4 weeks provided by Zahravi pharmaceutical Company, and then baseline and 4-weeks follow-up demographic data and questionnaire according to studies endpoints. Intervention 2: Control group: Identical placebo capsule similar to omega 3 capsule which has been provided by Zahravi pharmaceutical Company twice a day orally for 4 weeks and then baseline and 4-weeks follow-up demographic data and questionnaire according to studies endpoints. Yes - There is a plan to make this available What will be shared: All collected data When: From the summer of 2022 To whom: All academic centres Conditions: All documents with citation Where to obtain: From the main investigator, Azadeh Moghaddas via azadeh_moghaddas@yahoo.com address E-mail How to obtain: After sending a request, we will call the related person and the data will be revealed in less than one week Comments:
public Azadeh Moghaddas
Faculty of Pharmacy, Isfahan University of Medical Sciences, Hezar Jarib sreet, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7074 azadeh_moghaddas@yahoo.com Esfahan University of Medical Sciences scientific Azadeh Moghaddas
Faculty of Pharmacy, Isfahan University of medical Sciences, Hezar jarib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7074 azadeh_moghaddas@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Adult women suffering from hormone-positive breast cancer with grade I to III who are receiving Selective estrogen receptor modulators (SERM) or Aromatase inhibitors (AIs) family drug. Patients who are complaining from hot flash ( at least 4 times in a previous month) Patients who have compliance and ability to take omega 3 orally 18 years no limit Female Patients who are in metastatic stage Patients who have a history of other malignancies except for breast cancer Patients who are receiving antipsychotic, anti-depression, anti-anxiolytic, sedative or hypnotic or anti-epileptic drugs Patients with a history of hypersensitivity reaction to omega 3 C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: Omega 3 capsules 2 g daily (twice a day orally) for 4 weeks provided by Zahravi pharmaceutical Company, and then baseline and 4-weeks follow-up demographic data and questionnaire according to studies endpoints. Control group: Identical placebo capsule similar to omega 3 capsule which has been provided by Zahravi pharmaceutical Company twice a day orally for 4 weeks and then baseline and 4-weeks follow-up demographic data and questionnaire according to studies endpoints. The amount and severity of hot flash. Timepoint: Before intervention and 4 weeks. Method of measurement: Menopause Rating Scale (MRS) questionnaire. Sexual function. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Female Sexual Function Index questionnaire. Esfahan University of Medical Sciences Approved 2020-09-23 Ethics committee of Isfahan University of Medical Sciences Faculty of Pharmacy, Isfahan University of medical Sciences, Hezar jarib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)