ROLE OF FOLIC ACID IN THE MANAGEMENT OF ADJUVANT ENDOCRINE THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Folic Acid 1 Mg Oral Tablet, Folic Acid 5 Mg Oral Tablet.
- Who it may be relevant to
- Registry conditions: THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Folic Acid 1 Mg Oral Tablet
1 mg oral folic acid tablet - Drug Folic Acid 5 Mg Oral Tablet
5 mg oral folic acid tablet
Primary outcome measures
- Reduction in Hot Flash Frequency and Severity [Time frame: 3 months]
Secondary outcome measures (2)
- Improvement in Quality of Life [Time frame: 3 months]
- Correlation with Folic Acid Blood Levels [Time frame: 3 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06774885 · 15/2025