FOAM Trial, Version 1.0
Research type
Research Study
Full title
A phase III randomised study of folic acid supplementation in the management of menopausal symptoms in cancer survivors and healthy postmenopausal women
IRAS ID
135205
Contact name
Ayman Ewies
Contact email
Sponsor organisation
Sandwell And West Birmingham Hospitals NHS Trust
Eudract number
2013-004246-41
Research summary
Hot flushes, the most characteristic menopausal symptom, are experienced by 75% of menopausal women. Hot flushes are associated with deprivation of the oestrogen hormone; therefore, hormone replacement therapy is the primary treatment option. However, its use is associated with concerns over increased risk of breast cancer. Furthermore, its use in breast and endometrial cancer survivors is not welcomed because of the potential stimulation of residual cancer and non-hormonal alternatives which are commonly proposed to these women also show limited success.
It is observed in animal studies that folic acid administration may have a similar effect to oestrogen and ameliorate hot flushes by interacting with brain chemicals; reducing noradrenaline secretion and increasing serotonin activity. Furthermore, a small non-randomised study showed that daily folic acid supplementation not only improved hot flushes in postmenopausal Egyptian women but also reduced noradrenaline metabolite. These findings need to be confirmed in a larger better designed trial. FOAM is a phase III, double-blind, placebo-controlled randomised controlled trial designed to determine whether folic acid supplementation improves the frequency and severity of hot flushes in postmenopausal women, either healthy women or breast and endometrial cancer survivors compared to placebo. The frequency and severity of hot flushes will be recorded on self-reporting patient diaries. Effectiveness of folic acid supplementation on other menopausal symptoms, and quality of life will also be investigated. Blood and urine samples will be collected to explore the mechanism of action of folic acid and investigate the effect of folic acid supplementation on blood levels of serotonin and nor-adrenaline and their metabolites in the urine. If folic acid is demonstrated to be effective, it would represent a cheap, safe, well tolerated and easily deliverable alternative to the conventional hormone replacement therapy, particularly in cancer survivors who may be experiencing more intense symptoms and certainly cannot take hormone replacement therapy.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/0093
Date of REC Opinion
6 May 2014
REC opinion
Further Information Favourable Opinion