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

Future University in Egypt

Status and phase: Not yet enrolling; Phase 3

Conditions: THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS

Treatments: Drug: Folic Acid 1 Mg Oral Tablet; Drug: Folic Acid 5 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06774885

15/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Control

No Intervention group

Description:

The patient will not be administered with any drug/placebo

Intervention

Experimental group

Description:

1mg of folic acid

Treatment:

Drug: Folic Acid 1 Mg Oral Tablet

Treatment

Experimental group

Description:

5mg of folic acid

Treatment:

Drug: Folic Acid 5 Mg Oral Tablet