THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTSPhase 3NCT06774885
Role of Folic Acid in the Management of Adjuvant Endocrine Therapy-Induced Hot Flashes in Breast Cancer Patients
A Phase 3 study testing Folic Acid 1 Mg Oral Tablet and Folic Acid 5 Mg Oral Tablet in people with THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The study aims to assess the efficacy of folic acid supplementation at two doses (1 mg/day and 5 mg/day) in the management of hot flashes associated with adjuvant endocrine therapy among premenopausal breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS
- What is being tested?
- Folic Acid 1 Mg Oral Tablet and Folic Acid 5 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2025to 22 Oct 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Able to read and write to complete the study questionnaires and hot-flash diary.
Who cannot join
- Known hypersensitivity to folic acid
- Patients who have been treated with selective serotonin reuptake inhibitors (SSRIs) within the past 30 days.
- Metastatic breast cancer
- Renal impairment (Serum creatinine > 2 mg/dl)
- Significant liver disease: liver enzymes 2 folds the upper normal limit
- Taking other medication for hot flashes
- Medications inducing hot flashes such as (Clomiphene, Opioids, Nifedipine, Prednisone)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Breast Cancer Comprehensive Center (BCCC), National Cancer Institute (NCI), Cairo University, Egypt
Cairo
About this study
The study aims to assess the efficacy of folic acid supplementation at two doses (1 mg/day and 5 mg/day) in the management of hot flashes associated with adjuvant endocrine therapy among premenopausal breast cancer patients.
Read the 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 at two different doses (1 mg/day and 5 mg/day) in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.
- Being tested
- Folic Acid 1 Mg Oral Tablet, Folic Acid 5 Mg Oral Tablet
- Keywords
- Breast cancer, Hot flashes, Endocrine therapy, Folic acid
- Medical subject headings
- Breast Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic Acid 1 Mg Oral TabletDrug
Folic acid 1 mg oral tablet
Folic Acid 5 Mg Oral TabletDrug
Folic acid 5mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The patient will not be administered with any drug/placebo |
| Intervention | Experimental | Folic acid 1mg oral tablet Receives: Drug: Folic Acid 1 Mg Oral Tablet |
| Treatment | Experimental | Folic acid 5mg oral tablet Receives: Drug: Folic Acid 5 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start5 Apr 2025
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to three parallel groups according to their scheduled clinic attendance days. The study was open-label and nonrandomized, with a 1-week baseline period without supplementation followed by 11 weeks of active folic acid supplementation.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Cairo
- Responsible party
- Principal investigator, Fatma Abdalkarim, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774885
- Sponsor's protocol ID
- 15/2025
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No