THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS
Conditions
Keywords
Breast cancer, Hot flashes, Endocrine therapy, Folic acid
Brief summary
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.
Detailed description
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 in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.
Interventions
DRUGFolic Acid 1 Mg Oral Tablet
1 mg oral folic acid tablet
5 mg oral folic acid tablet
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Metastatic breast cancer * Taking other medication for hot flashes * Medications inducing hot flashes such as (Clomiphene, Opioids, Nifedipine, Prednisone)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Hot Flash Frequency and Severity | 3 months | It is measured using the daily hot flash diary, which tracks the number and intensity of hot flashes over the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life | 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. |
| Correlation with Folic Acid Blood Levels | 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. |
Contacts
Primary ContactFatma Abdalkarim Ibrahim, Bachelor's
Outcome results
None listed