]>
IRCT20221205056712N1 IRCT 2023-03-15 Hamedan University of Medical Sciences follow up of Effects of Melatonin on Health-Related Quality of Life The Effect of Melatonin on Increasing The Health-Related Quality of Life in Female Patients with Non-metastatic Breast Cancer: Three-year Follow up a Clinical Trial 2020-03-20 anticipated 64 Complete https://irct.ir/trial/67215 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Following the previous trial, in this study patients were followed up. During 3 years follow-up, patients were still taking melatonin in the case group and placebo in the control group, Randomization description: Any number of female breast cancer patients with stages I to III (according to the AJCC system) will be selected using a simple randomization method and randomly entered patients (random block) will be treated with melatonin or placebo (control group). . With the easy sampling method, eligible ones are randomly divided into intervention and control groups. In this study, the allocation of people to two groups will be done using permuted block technique. In this method, A represents the person who receives the intervention and B represents the person who is placed in the control group. Considering the quadruple block; We give code 0 to the AABB permutation, code 1 to the ABAB permutation, code 2 to ABBA, code 3 to BAAB, code 4 to BBAA and code 5 to 9 to BABA. Then, using the table of random numbers, we will randomly choose a starting point and then consider 21 numbers in rows or columns. Considering the order of the numbers in the table, for each number that we come across, we will assign its permutation, for example, if the first three numbers in the table of random numbers are 1, 0, and 5, then the order of receiving treatment by the first 12 people in the two groups, from left to right will be ABABAABBBABA. Therefore, finally, by choosing the appropriate number of numbers from the table, all the samples will be allocated into two groups, Blinding description: Blinding includes: Participants (patients) Clinical care provider ( radiotherapy-oncology physicians and chemotherapy nurses) The researcher and evaluator of the outcome and data analyzer (radiotherapy-oncology physician). In order to hide allocation, medicine, and placebo are put in similar envelopes in the opaque package, which has 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. 2-3 Breast Cancer; Health Related Quality of Life; Melatonin. Intervention 1: Intervention group: Oral Melatonin drug 6 mg (2 capsule of 3 mg) will be taken every night from 3 to 7 days before the start of the adjuvant treatment up to 3 years later. Intervention 2: Control group: The placebo will be taken every night from 3 to 7 days before the start of the adjuvant treatment until 3 years later. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Fateme Sheida
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1076 f.sheida@edu.umsha.ac.ir Hamedan University of Medical Sciences scientific Fateme Sheida
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1076 f.sheida@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 Receiving Adjuvant Chemotherapy and Radiotherapy 18 years no limit Female Not signing a written consent Untreated Hypercalcemia Systolic Blood Pressure Less Than 100 mm Hg Warfarin Consumption Methylphenidate Consumption Consumption of sleep Pills During Melatonin Use TSH>5/5 or <0/5 Pregnancy or Breastfeeding C50 Malignant neoplasm of breast Rehabilitation Rehabilitation Intervention group: Oral Melatonin drug 6 mg (2 capsule of 3 mg) will be taken every night from 3 to 7 days before the start of the adjuvant treatment up to 3 years later. Control group: The placebo will be taken every night from 3 to 7 days before the start of the adjuvant treatment until 3 years later Quality of life. Timepoint: 3 years after last adjuvant treatment session. Method of measurement: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Hamedan University of Medical Sciences Approved 2023-01-21 Ethics committee of Hamadan University of Medical Sciences Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan Hamadan Hamadan Iran (Islamic Republic of)