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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-09

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

The patient will not be administered with any drug/placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

1mg of folic acid

Group Type EXPERIMENTAL

Folic Acid 1 Mg Oral Tablet

Intervention Type DRUG

1 mg oral folic acid tablet

Treatment

5mg of folic acid

Group Type EXPERIMENTAL

Folic Acid 5 Mg Oral Tablet

Intervention Type DRUG

5 mg oral folic acid tablet

Interventions

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Folic Acid 1 Mg Oral Tablet

1 mg oral folic acid tablet

Intervention Type DRUG

Folic Acid 5 Mg Oral Tablet

5 mg oral folic acid tablet

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Fatma Abdalkarim

Teaching Assistant- Pharmacy Practice & Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Fatma Abdalkarim Ibrahim, Bachelor's

Role: CONTACT

01005337309

Other Identifiers

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15/2025

Identifier Type: -

Identifier Source: org_study_id

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