Breast Cancer Comprehensive Center (BCCC), National Cancer Institute (NCI), Cairo University, Egypt
Cairo, Egypt
NCT Number: NCT06774885
The study aims to assess the efficacy of folic acid supplementation at two doses (1 mg/day and 5 mg/day) in the management of hot flashes associated with adjuvant endocrine therapy among premenopausal breast cancer patients.
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Notify Me18 year–45 year
Female
Interventional
Phase 3
Cairo, Egypt
Folic acid is one of the B vitamins that when absorbed into its active form is converted to tetrahydrofolate. Folate is an essential cofactor for the biosynthesis of norepinephrine and serotonin. Studies have also noted that folate, with a mechanism like hormone replacement therapy (HRT), can improve hot flashes by interfering with monoamine neurotransmitters called norepinephrine and serotonin .The purpose of the current study is to investigate the role of folic acid administration at two different doses (1 mg/day and 5 mg/day) in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Folic acid 1 mg oral tablet
Folic acid 5mg oral tablet
Time frame: 3 months
It is measured using the daily hot flash diary, which tracks the number and intensity of hot flashes over the study period.
Time frame: 3 months
Assessed through the Hot Flash Related Daily Interference Scale (HFRDIS), which evaluates how hot flashes interfere with daily activities and overall well-being.
Time frame: 3 months
Folic acid levels in the blood will be measured to explore the relationship between serum folate concentrations and changes in hot flashes symptoms.
Future University in Egypt
Other
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