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IRCT20150726023349N4 IRCT 2018-02-15 Tehran University of Medical Sciences Effect of melatonin on sleep quality in breast cancer patients during chemotherapy Comparison evaluation of sleep disorders incidence in patients with primary breast cancer admitted to Imam Khomeini hospital in Tehran received melatonin during adjuvant chemotherapy 2017-09-23 anticipated 120 Complete https://irct.ir/trial/19932 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly placed in blocks of 6. In each block, 3 patients receive melatonin and 3 patients receive placebo, Blinding description: The randomization is done by Dr. Jahangard and only she knows the type of drug prescribed to each patient.The encoded drug packs will be placed at the outpatient chemotherapy pharmacy located at the Cancer Institute, and will be delivered to the patient in accordance with the code given to each patient. N/A Breast cancer. Intervention 1: Intervention group: 120 patients with breast cancer stage one to three who have undergone cancer surgery in the last three months are enrolled to receive standard adjuvant chemotherapy. Of the 120 patients, 60 were randomly selected and placed in the intervention group. At first, psychiatric interview will be perform to exclude patients with sleep disorders, depression and anxiety required drug administration. Patients will be evaluate with Pittsburgh questionnaire three times (before, after the fourth turn, and at the end of chemotherapy) to assess sleep quality.Chemotherapy will be administered according to the dose dense protocol, cyclophosphamide dosage of 600 mg per body surface, and adriamycin 60 mg per body surface area every four weeks for four times, followed by 80 mg / kg body weight per week for 12 times. It is worth noting that trastuzumab will be prescribed if HER2 is positive in immunohistochemical staining and in the absence of a cardiac prohibition. In the first injection 8 mg per body weight, and at a subsequent dose of 6 mg per body weight, every 3 weeks, trastuzumab will be infused. In the case of platelets less than 100,000, or white blood cells less than 2000 per micro-liter at the time of chemotherapy, that chemotherapy session will be delayed until cytopenia improve to the extent indicated.Intervention in this group is given as two 3 mg melatonin tablets (N-Acetyl-5-methoxytryptamine), manufactured by Razak Laboratories, each night at 8 pm during chemotherapy for 6 months.Possible side effects of melatonin include: 1- Sensitization reaction (shortness of breath, skin rash) 2- Daytime sleepiness 3 - Nightmare 4 - Headache. The following measures are recommended when complications occur: 1- Discontinue the medication and see a physician as soon as possible. 2- If severe signs of allergy occur, take one tablet of loratadine and go to the emergency department. Intervention 2: Control group: 120 patients with breast cancer stage one to three who have undergone cancer surgery in the last three months are enrolled to receive standard adjuvant chemotherapy. Of the 120 patients, 60 were randomly selected and placed in the intervention group, and 60 others were randomly assigned to the control group. Like the intervention group, at first, psychiatric interview will be perform to exclude patients with sleep disorders, depression and anxiety required drug administration. Patients will be evaluated with Pittsburgh questionnaire three times (before, after the fourth turn, and at the end of chemotherapy) to assess sleep quality. Chemotherapy will be administered according to the dose dense protocol, cyclophosphamide dosage of 600 mg per body surface, and adriamycin 60 mg per body surface area every four weeks for four times, followed by 80 mg / kg body weight per week for 12 times. It is worth noting that trastuzumab will be prescribed if HER2 is positive in immunohistochemical staining and in the absence of a cardiac prohibition. In the first injection 8 mg per body weight, and at a subsequent dose of 6 mg per body weight, every 3 weeks, trastuzumab will be infused. In the case of platelets less than 100,000, or white blood cells less than 2000 per micro-liter at the time of chemotherapy, that chemotherapy session will be delayed until cytopenia improve to the extent indicated.In this group, during chemotherapy for 6 months patients are given 2 placebo tablets with the same appearance as melatonin tablets take the intervention group, every night at 8 pm. Placebo tablets are also produced by Razak Laboratories. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its program has not yet been determined.
public Dr Mohsen Seddigh Shamsi
Keshavarz Boulevard, Cornre of the Ghods Street
Tehran Iran (Islamic Republic of) 1417653761 +98 21 81631 mseddighshamsi@gmail.com Tehran University of Medical Sciences scientific Dr Mohsen Esfandbod
Keshavarz Boulevard, Cornre of the Ghods Street
Tehran Iran (Islamic Republic of) 1417653761 +98 21 81631 sfandbod@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who are in stage one to three breast cancer and cancer surgery is performed within the last three months. No history of prior chemotherapy No contraindication for adjuvant chemotherapy of breast cancer (including heart failure and drug hypersensitivity) 40 to 60 years old at the onset of chemotherapy The absence of uncontrolled diabetes and renal failure with glomerular filtration less than 30 40 years 60 years Female Delay or discontinuation of chemotherapy over one month for any reason Sleep disorder, depression and anxiety requiring drug treatment C50.9 Malignant neoplasm: Breast, unspecified Treatment - Drugs Placebo Intervention group: 120 patients with breast cancer stage one to three who have undergone cancer surgery in the last three months are enrolled to receive standard adjuvant chemotherapy. Of the 120 patients, 60 were randomly selected and placed in the intervention group. At first, psychiatric interview will be perform to exclude patients with sleep disorders, depression and anxiety required drug administration. Patients will be evaluate with Pittsburgh questionnaire three times (before, after the fourth turn, and at the end of chemotherapy) to assess sleep quality.Chemotherapy will be administered according to the dose dense protocol, cyclophosphamide dosage of 600 mg per body surface, and adriamycin 60 mg per body surface area every four weeks for four times, followed by 80 mg / kg body weight per week for 12 times. It is worth noting that trastuzumab will be prescribed if HER2 is positive in immunohistochemical staining and in the absence of a cardiac prohibition. In the first injection 8 mg per body weight, and at a subsequent dose of 6 mg per body weight, every 3 weeks, trastuzumab will be infused. In the case of platelets less than 100,000, or white blood cells less than 2000 per micro-liter at the time of chemotherapy, that chemotherapy session will be delayed until cytopenia improve to the extent indicated.Intervention in this group is given as two 3 mg melatonin tablets (N-Acetyl-5-methoxytryptamine), manufactured by Razak Laboratories, each night at 8 pm during chemotherapy for 6 months.Possible side effects of melatonin include: 1- Sensitization reaction (shortness of breath, skin rash) 2- Daytime sleepiness 3 - Nightmare 4 - Headache. The following measures are recommended when complications occur: 1- Discontinue the medication and see a physician as soon as possible. 2- If severe signs of allergy occur, take one tablet of loratadine and go to the emergency department. Control group: 120 patients with breast cancer stage one to three who have undergone cancer surgery in the last three months are enrolled to receive standard adjuvant chemotherapy. Of the 120 patients, 60 were randomly selected and placed in the intervention group, and 60 others were randomly assigned to the control group. Like the intervention group, at first, psychiatric interview will be perform to exclude patients with sleep disorders, depression and anxiety required drug administration. Patients will be evaluated with Pittsburgh questionnaire three times (before, after the fourth turn, and at the end of chemotherapy) to assess sleep quality. Chemotherapy will be administered according to the dose dense protocol, cyclophosphamide dosage of 600 mg per body surface, and adriamycin 60 mg per body surface area every four weeks for four times, followed by 80 mg / kg body weight per week for 12 times. It is worth noting that trastuzumab will be prescribed if HER2 is positive in immunohistochemical staining and in the absence of a cardiac prohibition. In the first injection 8 mg per body weight, and at a subsequent dose of 6 mg per body weight, every 3 weeks, trastuzumab will be infused. In the case of platelets less than 100,000, or white blood cells less than 2000 per micro-liter at the time of chemotherapy, that chemotherapy session will be delayed until cytopenia improve to the extent indicated.In this group, during chemotherapy for 6 months patients are given 2 placebo tablets with the same appearance as melatonin tablets take the intervention group, every night at 8 pm. Placebo tablets are also produced by Razak Laboratories. Sleep quality. Timepoint: Before start of chemothrapy, after forth cycle and at of the chemothrapy. Method of measurement: Pittsburgh sleep quality index. Tehran University of Medical Sciences Approved 2017-06-12 Tehran University of Medical Sciences Keshavarz Boulevard, Cornre of the Ghods Street, Central Organization of Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)