]>
IRCT20180426039421N1 IRCT 2018-06-16 Hamedan University of Medical Sciences Effect of Melatonin Drug in Decreasing Fatigue Caused by Radiotherapy and Chemotherapy Evaluation of the Effect of Melatonin Drug in Decreasing Fatigue Caused by Adjuvant Radiotherapy and Chemotherapy in Women with Breast Cancer: A Clinical Trial 2018-10-07 anticipated 64 Complete https://irct.ir/trial/30998 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Any number of female breast cancer patients with stage I-III( according to the AJCC system) are selected by simple randomization method and the patients are randomized (randomized block design) to receive melatonin or placebo (control group) , Blinding description: Blinding includes: Participants( patients) Clinical care provider( radiotherapy-oncology physicians and chemotherapy nurses) Researcher and evaluator of the outcome and data analyzer: (radiotherapy-oncology resident) In order to hide allocation, medicine and placebo are put in similar envelopes in the opaque package, which have been numbered. Blocking and preparation of envelopes are performed by a non-involved person in data sampling and analysis. Thus, the clinical care provider, the data collector, the participant and the data analyst, are unaware of the type of intervention received and who is located in each group. 3 Breast Cance; Cancer Related Fatigue; Melatonin. Intervention 1: Intervention group: Oral Melatonin drug 6 mg( 2 capsule of 3 mg) every night from 3 to 7 days before the start of Adjuvant treatmentwill be used until the disease progresses. Intervention 2: Control group: The placebo will be taken every night from 3 to 7 days before the start of the adjuvant treatment until the disease progresses. 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 No more information
public Zahra Kesht Pour Amlashi
MRI and Radiotherapy Center of Mahdie, Parastar Ave., Besat Blvd.
Hamadan Iran (Islamic Republic of) 8138381225 +98 81 3838 1076 z.keshtpour@edu.umsha.ac.ir Hamedan University of Medical Sciences scientific Zahra Kesht Pour Amlashi
MRI and Radiotherapy Center of Mahdie, Parastar Ave., Besat Blvd.
Hamadan Iran (Islamic Republic of) 8138381225 +98 81 3838 1076 z.keshtpour@edu.umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Breast Cancer Stages I, II, III According to Pathological Reports Patients at least 18 Years Old Have Signed a Written Consent Recevieng Adjuvant Chemotherapy and Radiotherapy No Untreated Hypercalcemia No Systolic Blood Pressure Less Than 100 mm Hg No Warfarin Consumption No Methylphenidate Consumption No Sleep Pills During Melatonin Use No TSH>5/5 or <0/5 No Pregnancy or Breastfeeding 18 years no limit Female Expired During Treatment Stop Using Melatonin during Treatment C50 Malignant neoplasm of breast Rehabilitation Placebo Intervention group: Oral Melatonin drug 6 mg( 2 capsule of 3 mg) every night from 3 to 7 days before the start of Adjuvant treatmentwill be used until the disease progresses Control group: The placebo will be taken every night from 3 to 7 days before the start of the adjuvant treatment until the disease progresses Fatigue severity in the BFI questionnaire. Timepoint: 4 weeks after last adjuvant treatment session. Method of measurement: Brief Fatigue Inventory( BFI) questionnaire. Hamedan University of Medical Sciences Approved 2018-04-21 Ethics committee of Hamedan University of Medical Sciences Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan Hamedan Hamadan Iran (Islamic Republic of)