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NCT Number: NCT06774885

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

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.

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Key information

Conditions

THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS Breast Diseases Breast Neoplasms Hot Flashes Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Folic Acid 1 Mg Oral Tablet

Drug

1 mg oral folic acid tablet

Folic Acid 5 Mg Oral Tablet

Drug

5 mg oral folic acid tablet

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Abdalkarim Ibrahim, Bachelor's

CONTACT

[email protected]

01005337309

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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