About this trial
The study's objective is to investigate the role of folic acid administration in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females older than 18 years
Diagnosed with confirmed breast cancer and currently treated with an adjuvant endocrine
Experiencing bothersome hot flashes at least 14 times/week
Taking the treatment within 6 months to two years.
Disqualifiers
Known hypersensitivity to folic acid
Patients who have been treated with selective serotonin reuptake inhibitors (SSRIs) within the past 30 days.
Renal impairment is defined as a serum creatinine level greater than 2 mg/ld..
Significant liver disease: Indicated by liver enzyme levels exceeding two times the upper limit of normal.
Trial design
Parallel
Treatments tested in this trial
Folic Acid 1 Mg Oral Tablet
Drug1 mg oral folic acid tablet
Folic Acid 5 Mg Oral Tablet
Drug5 mg oral folic acid tablet
Treatment groups
Trial outcomes
Primary outcomes
Reduction in Hot Flash Frequency and Severity
It is measured using the daily hot flash diary, which tracks the number and intensity of hot flashes over the study period.
Secondary outcomes
Improvement in Quality of Life
Assessed through the Hot Flash Related Daily Interference Scale (HFRDIS), which evaluates how hot flashes interfere with daily activities and overall well-being.
Correlation with Folic Acid Blood Levels
Folic acid levels in the blood will be measured to explore the relationship between serum folate concentrations and changes in hot flashes symptoms.
Locations
Sponsors and contacts
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