Clinical trial · Interventional
Role of Folic Acid in the Management of Adjuvant Endocrine Therapy-Induced Hot Flashes in Breast Cancer Patients
NCT06774885CI-TRIAL-00084683completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folic Acid 1 Mg Oral Tablet | Drug | — | UNRESOLVED |
| Folic Acid 5 Mg Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control
- description
- The patient will not be administered with any drug/placebo
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Folic acid 1mg oral tablet
- interventionNames
- Drug: Folic Acid 1 Mg Oral Tablet
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Folic acid 5mg oral tablet
- interventionNames
- Drug: Folic Acid 5 Mg Oral Tablet
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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. * Able to read and write to complete the study questionnaires and hot-flash diary. Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.