breast cancer. Malignant neoplasm of breast
Conditions
Interventions
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
Sponsors
Sabzevar University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShervin Mashreghi moghaddam
Mashhad University of Medical Sciences
Outcome results
None listed