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

NCT06774885 | Not Yet Recruiting Phase 3

• 1 other identifier: 15/2025
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS

Keywords

Breast cancer; Hot flashes; Endocrine therapy; Folic acid

Outcome Measures

Primary Outcomes (1)

• Reduction in Hot Flash Frequency and Severity

  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 Outcomes (2)

• Improvement in Quality of Life

  3 months

• Correlation with Folic Acid Blood Levels

  3 months

Study Arms (3)

Control

NO INTERVENTION

The patient will not be administered with any drug/placebo

Intervention

EXPERIMENTAL

1mg of folic acid

Drug: Folic Acid 1 Mg Oral Tablet

Treatment

EXPERIMENTAL

5mg of folic acid

Drug: Folic Acid 5 Mg Oral Tablet

Interventions

Folic Acid 1 Mg Oral Tablet DRUG

1 mg oral folic acid tablet

Intervention

Folic Acid 5 Mg Oral Tablet DRUG

5 mg oral folic acid tablet

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Future University in Egypt: lead

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Interventions

Folic Acid; Tablets

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Fatma Abdalkarim Ibrahim, Bachelor's

CONTACT

01005337309; fatma.ibrahim@fue.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant- Pharmacy Practice & Clinical Pharmacy

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: February 9, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share