Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFuture University in Egypt
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
Qualifiers
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
Treatments tested in this trial
- Folic Acid 1 Mg Oral Tablet
- Folic Acid 5 Mg Oral Tablet
Treatment groups
120 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov