ROLE OF FOLIC ACID IN THE MANAGEMENT OF ADJUVANT ENDOCRINE THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS

Phase 3

Not yet recruiting

• Conditions: THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS
• Interventions: Drug: Folic Acid 1 Mg Oral Tablet; Drug: Folic Acid 5 Mg Oral Tablet

• Registration Number: NCT06774885
• Lead Sponsor: Future University in Egypt

Brief Summary

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-02-09
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Folic Acid 1 Mg Oral Tablet	1mg of folic acid
Treatment	Folic Acid 5 Mg Oral Tablet	5mg of folic acid

Primary Outcome Measures

Name	Time	Method
Reduction in Hot Flash Frequency and Severity	3 months	It is measured using the daily hot flash diary, which tracks the number and intensity of hot flashes over the study period.

Secondary Outcome Measures

Name	Time	Method
Improvement in Quality of Life	3 months	Assessed through the Hot Flash Related Daily Interference Scale (HFRDIS), which evaluates how hot flashes interfere with daily activities and overall well-being.
Correlation with Folic Acid Blood Levels	3 months	Folic acid levels in the blood will be measured to explore the relationship between serum folate concentrations and changes in hot flashes symptoms.