A Phase 3 interventional study of Folic Acid 1 Mg Oral Tablet and Folic Acid 5 Mg Oral Tablet in THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Future University in Egypt · Phase 3, Interventional, and Treatment
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Future University in Egypt is the lead sponsor of 104 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient will not be administered with any drug/placebo
Folic acid 1mg oral tablet
Drug: Folic Acid 1 Mg Oral Tablet
Folic acid 5mg oral tablet
Drug: Folic Acid 5 Mg Oral Tablet
Folic acid 1 mg oral tablet
Folic acid 5mg oral tablet
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Folic Acid