ROLE OF FOLIC ACID IN THE MANAGEMENT OF ADJUVANT ENDOCRINE THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS
NCT ID: NCT06774885
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2025-02-09
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
The patient will not be administered with any drug/placebo
No interventions assigned to this group
Intervention
1mg of folic acid
Folic Acid 1 Mg Oral Tablet
1 mg oral folic acid tablet
Treatment
5mg of folic acid
Folic Acid 5 Mg Oral Tablet
5 mg oral folic acid tablet
Interventions
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Folic Acid 1 Mg Oral Tablet
1 mg oral folic acid tablet
Folic Acid 5 Mg Oral Tablet
5 mg oral folic acid tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
FEMALE
No
Sponsors
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Future University in Egypt
OTHER
Responsible Party
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Fatma Abdalkarim
Teaching Assistant- Pharmacy Practice & Clinical Pharmacy
Central Contacts
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Other Identifiers
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15/2025
Identifier Type: -
Identifier Source: org_study_id
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