Study Oversight
The trial is titled: Phase III randomised study of FO licA cid supplementation in the management of M enopausal
symptoms in cancer survivors and healthy postmenopausal women (FOAM
Trial). It was co-sponsored by Sandwell and West Birmingham Hospitals
NHS Trust and University of Birmingham, and was conducted under the
auspices of the Cancer Research UK
Clinical Trial Unit (CRCTU Ref No.: MX3009). Guys’ and St Thomas’
Hospital Pharmacy Manufacturing Unit was responsible for purchasing the
trial drug from Actavis (Devon, UK, rebranded as Accord Healthcare in
January 2017), and for manufacturing the placebo tablets. Study
oversight and monitoring were provided by a trial steering committee and
by an independent data and safety monitoring committee. The trial
protocol and ethical approval are submitted as Supplementary Document 1
and 2, respectively.