Two-year follow up of a Randomized, Controlled Trial: the Effects of Melatonin on Fatigue Associated with Breast Cancer and Its Adjuvant Treatments

Determining the Effect of Melatonin in Decresing Fatigue associated with Adjuvant Radiation therapy and Chemotherapy in Breast Cancer Patients follow up

Phase 2-3 clinical trial with 64 patients with control group, with parallel groups, triple blinded, with a randomized block design

Female patients with breast cancer,stages I to III admitted at Mahdieh Diagnostic and Therapeutic Center and Besat Hospital for adjuvant radiation therapy and chemotherapy during 1398, were selected using simple randomization method and with full explanation of the study and and Written consent. The admitted patients were randomly (randomly blocked) treated with melatonin or placebo (control group). for blinding ,melatonin and the placebo were placed in similar envelopes in a matte package numbered consecutively.Blocking and preparation of envelopes was done by a non-involved person in data sampling and analysis, and thus the health care provider, the data collector, the participant and the person analyzing the data, were not aware of the intervention type received, and Who is located in each group.in this study, the patients have been followed up for 2 years still taking melatonin in the case group and placebo in the control group

Female breast cancer patients with stage I-III(AJCC) who receive adjuvant chemotherapy and radiation therapy.

Admitted patients will be randomly assigned to melatonin or placebo(control).Oral melatonin 6 mg (in the form of 2 capsules of 3 mg) will be taken every night from 3-7 days before the start of adjuvant treatment for up to 2 years. Following the previous study, patients have been followed up for 2 years, still taking melatonin in the case group and placebo in the control group.

Fatigue severity

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, 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 AABB permutation, code 1 to 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 includes: Participants( patients) Clinical care provider( radiotherapy-oncology physicians and chemotherapy nurses) 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 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.

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