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

January 9, 2025 updated by: Fatma Abdalkarim, Future University in Egypt
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The patient will not be administered with any drug/placebo
Experimental: Intervention
1mg of folic acid
Drug: Folic Acid 1 Mg Oral Tablet
1 mg oral folic acid tablet
Experimental: Treatment
5mg of folic acid
Drug: Folic Acid 5 Mg Oral Tablet
5 mg oral folic acid tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Quality of Life
Time Frame: 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.
3 months
Correlation with Folic Acid Blood Levels
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 9, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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