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IRCT20250314065072N1 IRCT 2025-03-23 Sabzevar University of Medical Sciences A study on the effects of melatonin supplementation in improving chemotherapy-induced fatigue in breast cancer patients over 50 years old A study on the effects of melatonin supplementation in improving chemotherapy-induced fatigue in breast cancer patients over 50 years old 2025-04-05 anticipated 72 Complete https://irct.ir/trial/82495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: A four-block randomization method will be used to assign participants to groups. To allocate 36 samples per group (72 total participants), 18 blocks of 4 are needed. To select the 18 blocks, 18 random numbers between 1 and 6 will be generated with replacement. Thus, a sequence of letters A and B, including 72 letters (36 A's and 36 B's), will be created. Based on the generated sequence, participants will be assigned to groups in order. The random numbers generated in the R software and the random block assigned to the generated numbers. For example, the first person who meets the inclusion criteria for the study will be placed in group B, the second person in group B, the third person in group A, and the fourth person in group A, and so on up to 72 people, Blinding description: Participants, principal investigator, healthcare personnel (doctors, nurses, etc.) responsible for patient care, data collectors, outcome assessors, and those who prepare the manuscript draft. 3 breast cancer. Intervention 1: Intervention group: will receive 5 mg of melatonin produced by Tehran Darou Pharmaceutical Company daily from one week before the start of chemotherapy to one month after the end of it. Intervention 2: Control group: will receive placebo daily from one week before the start of chemotherapy to one month after the end of it. Yes - There is a plan to make this available What will be shared: All potential data is shareable after de-identifying individuals When: Access period begins after results are published To whom: Our data will only be accessible to researchers employed in academic and scientific institutions Conditions: To conduct other similar academic and scientific studies Where to obtain: Via Shervin Mashreghi Moghaddam's email bdmashreghi@gmail.com How to obtain: The applicant must provide documentation of their academic and university position, the title of the study, and the type of data usage Comments:
public Shervin Mashreghi moghaddam
Omid hospital., Koohsangi Ave
Mashhad Iran (Islamic Republic of) 9175995957 +98 51 3843 9335 bdmashreghi@gmail.com Mashhad University of Medical Sciences scientific Shervin Mashreghi moghaddam
Omid hospital., Koohsangi Ave
Mashhad Iran (Islamic Republic of) 9175995957 +98 51 3843 9335 bdmashreghi@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Informed Consent for Study Participation Patients with breast cancer over 50 years old who require adjuvant or neoadjuvant chemotherapy. Patients with a functional level of 0 or 1 based on the Eastern Cooperative Oncology Performance Status (ECOG PS) questionnaire. 50 years no limit Female Patients with known underlying conditions including uncontrolled diabetes, uncontrolled high blood pressure, cardiovascular diseases and heart failure, chronic kidney disease, chronic liver disease, autoimmune disease, obstructive respiratory disease, uncontrolled thyroid disorder, history of stroke, seizures, and mental disorder requiring medication. Use of sleep aids or fatigue-reducing medications prior to the start of the intervention. Unwillingness to continue cooperation in the study. Lifestyle that interferes with the nocturnal sleep rhythm (e.g., those who work night shifts). Previous history of chemotherapy. Diagnosis of metastasis. Development of severe toxicities that could not be controlled with standard doses, such as nausea. C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: will receive 5 mg of melatonin produced by Tehran Darou Pharmaceutical Company daily from one week before the start of chemotherapy to one month after the end of it Control group: will receive placebo daily from one week before the start of chemotherapy to one month after the end of it Fatigue score in FACIT-Fatigue. Timepoint: evaluation of the fatigue score one week before intervention, after chemotherapy and one month after the end of chemotherapy. Method of measurement: FACIT-Fatigue quastionaire. Sabzevar University of Medical Sciences Approved 2025-03-08 Sabzevar University of Medical Sciences Vice-Chancellor for Research and Technology, Campus of Sabzevar University of Medical Sciences, after the shohada gomnam Memorial, shohada hasteyi Boulevard. sabzevar Razavi Khorasan Iran (Islamic Republic of)