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IRCT20190630044057N1 IRCT 2019-09-28 Tehran University of Medical Sciences Effect of Melatonin on arthralgia-myalgia of Paclitaxel The effect of melatonin on incidence and severity of arthralgia-myalgia caused by weekly paclitaxel in patients with breast cancer 2019-09-23 anticipated 62 Complete https://irct.ir/trial/41964 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Prevention, Blinding description: This study is a double blind clinical trial conducted at Cancer Institute Clinic. Patients fall into two groups using block randomization. One group received placebo with chemotherapy and the other received melatonin with chemotherapy. 3 Breast cancer. Intervention 1: Intervention group: Melatonin with dose of 10 mg from Best naturals company will be prescribed every night from the day Paclitaxel administration to one week period for 12 weeks. Intervention 2: Control group: One tablet of Placebo will be prescribed every night from the day Paclitaxel administration to one week period for 12 weeks. Yes - There is a plan to make this available What will be shared: The data like patient inventory data and effects of Melatonin and side effects of chemotherapy will be published in form of article When: At the end of study and after publication To whom: Scientific researchers Conditions: For more researches Where to obtain: Zahra Jahangard-Rafsanjani How to obtain: After acceptance by Zahra Jahangard-Rafsanjani Comments:
public Zahra Jahangard-Rafsanjani
Keshavarz Ave
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1692 zjahangard@sina.tums.ac.ir Tehran University of Medical Sciences scientific Zahra Jahangard-Rafsanjani
Keshavarz Ave
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1692 zjahangard@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women with Breast Cancer and Candidate receiving Paclitaxel 80 mg / m 2 weekly for 12 weeks after doxorubicin + cyclophosphamide regimen Age over 18 years Ability to take oral medication Ability to fill out a questionnaire Not taking pain relief medication for chronic No peripheral neuropathy No history of fibromyalgia, Rheumatoid arthritis, Osteoarthritis No history of receiving paclitaxel or any other drug with neurotoxicity Uncontrolled diabetes no history of receiving alcohol, statin, colchicine, zidovudine, penicillamine. no history of metastatic disease 18 years no limit Female Patients with concurrent GCSF administration Patients who experience trauma or falling during the study Viral Respiratory Infection During Study C50 Malignant neoplasm of breast Prevention Prevention Intervention group: Melatonin with dose of 10 mg from Best naturals company will be prescribed every night from the day Paclitaxel administration to one week period for 12 weeks. Control group: One tablet of Placebo will be prescribed every night from the day Paclitaxel administration to one week period for 12 weeks. Arthralgia. Timepoint: Arthralgia before Paclitaxel administration and daily after. Method of measurement: Brief Pain Inventory (BPI) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE). Myalgia. Timepoint: Myalgia before Paclitaxel administration and daily after. Method of measurement: Brief Pain Inventory (BPI) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE). Neuropathy. Timepoint: neuropathy before Paclitaxel administration and weekly after. Method of measurement: Douleur Neuropathique 4 Questions (DN4) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE). Tehran University of Medical Sciences Approved 2019-08-05 Ethics committee of the institute of pharmaceutical sciences Tehran university of medical sciences Tehran university of medical sciences Tehran Tehran Iran (Islamic Republic of)