Role of Folic Acid in the Management of Adjuvant Endocrine Therapy-Induced Hot Flashes in Breast Cancer Patients

Sex: Female

Ages: 18 Years – 45 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 120

Sponsor: Future University in Egypt

Location: Breast Cancer Comprehensive Center (BCCC), National Cancer Institute (NCI), Cairo University, Egypt Cairo

Summary

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.

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. * Able to read and write to complete the study questionnaires and hot-flash diary. Exclusion Criteria: * Known hypersensitivity to folic acid * Patients who have been treated with selective serotonin reuptake inhibitors (SSRIs) within the past 30 days. * Metastatic breast cancer * Renal impairment (Serum creatinine \> 2 mg/dl) * Significant liver disease: liver enzymes 2 folds the upper normal limit * Taking other medication for hot flashes * Medications inducing hot flashes such as (Clomiphene, Opioids, Nifedipine, Prednisone)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06774885). StuddyBuddy aggregates publicly available trial information.