A completed phase 3 interventional trial conducted at Future University in Egypt assessed whether folic acid supplementation at 1 mg/day or 5 mg/day can reduce the frequency or severity of hot flashes induced by adjuvant endocrine therapy in premenopausal breast cancer patients. Full efficacy results have not yet been publicly reported.
A phase 3 interventional trial registered on ClinicalTrials.gov (NCT06774885) has completed enrollment and intervention, examining the potential role of folic acid in alleviating vasomotor symptoms—specifically hot flashes—that commonly arise as a side effect of adjuvant endocrine therapy in premenopausal women with breast cancer. The trial compared two oral dosing regimens: 1 mg/day and 5 mg/day of folic acid.
Hot flashes represent one of the most frequently reported and treatment-limiting adverse effects of adjuvant endocrine agents such as tamoxifen and aromatase inhibitors, contributing to reduced adherence and diminished quality of life in this population. Current pharmacological options for managing these vasomotor symptoms in hormone receptor-positive breast cancer survivors are constrained by concerns over hormonal interventions and limited evidence for non-hormonal alternatives.
Folic acid has been proposed as a low-cost, widely available supplement with a favorable safety profile that may modulate vasomotor symptom pathways, though the precise mechanism in this context remains under investigation. The dose-comparison design of this trial may help clarify whether a therapeutic threshold exists and inform future prescribing guidance if efficacy is confirmed. Results from this completed trial have not yet been published or publicly disclosed at the time of this report.
Key points
- Phase 3 trial (NCT06774885) completed at Future University in Egypt comparing folic acid 1 mg/day vs. 5 mg/day for adjuvant endocrine therapy-induced hot flashes
- Target population: premenopausal women with breast cancer receiving adjuvant endocrine therapy
- Primary objective was to assess efficacy of folic acid supplementation in reducing vasomotor symptoms
- Hot flashes are a leading cause of non-adherence to adjuvant endocrine regimens in this demographic
- Full trial results have not yet been publicly reported; clinical implications remain pending
Why it matters
Vasomotor symptoms are a significant driver of adjuvant endocrine therapy discontinuation in premenopausal breast cancer patients, and safe, evidence-based non-hormonal interventions remain limited. If folic acid supplementation demonstrates meaningful efficacy, it could offer a low-cost, accessible option to improve treatment tolerability and adherence.