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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFuture University in Egypt

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Group C: TreatmentExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

Improvement in Quality of Life

Assessed through the Hot Flash Related Daily Interference Scale (HFRDIS), which evaluates how hot flashes interfere with daily activities and overall well-being.

Time frame
3 months
2

Correlation with Folic Acid Blood Levels

Folic acid levels in the blood will be measured to explore the relationship between serum folate concentrations and changes in hot flashes symptoms.

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: