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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The patient will not be administered with any drug/placebo | |
| Intervention | Experimental | 1mg of folic acid |
|
| Treatment | Experimental | 5mg of folic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid 1 Mg Oral Tablet | Drug | 1 mg oral folic acid tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Correlation with Folic Acid Blood Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma Abdalkarim Ibrahim, Bachelor's | Contact | 01005337309 | fatma.ibrahim@fue.edu.eg |
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| Folic Acid 5 Mg Oral Tablet |
| Drug |
5 mg oral folic acid tablet |
|
Folic acid levels in the blood will be measured to explore the relationship between serum folate concentrations and changes in hot flashes symptoms.
| 3 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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