FOAM: A phase III randomised study of FOlic Acid supplementation in the management of Menopausal symptoms in cancer survivors and healthy postmenopausal women.

Trial Overview and Summary

This trial is recruiting healthy women who are postmenopausal or cancer survivors (breast or endometrial) who have entered the menopause. Participants must be aged between 40-70 years of age and suffer >50 hot flushes each week. Further eligibility checks will be undertaken before entering the trial. Suitable participants are randomly allocated to receive folic acid or a matched placebo tablet once daily for 12 weeks. Participants will need to attend 6 hospital visits during the trial. Questionnaires to assess menopausal symptoms and Quality of Life and blood and urine samples will be taken at some visits. 

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.


Chief Investigator: Mr Ayman Ewies
Sponsor: Sandwell and West Birmingham Hospitals NHS Trust and University of Birmingham
Funders: National Institute for Health Research, Research for Patient Benefit (NIHR RfPB)
Disease Site: Healthy Women or Cancer Survivors (Breast or Endometrial)
Trial Type: Clinical Trial of an Investigational Medicinal Product
Status: Open (Closed to recruitment) 
Site names:

Leicester Royal Infirmary
Birmingham City Hospital
Macclesfield District General Hospital
Northwick Park Hospital, Harrow
University Hospital Coventry
Solihull Hospital, Birmingham
Queen’s Hospital Burton
Royal Shrewsbury Hospital
New Cross Hospital, Wolverhampton

UKCRN Study ID: (if applicable)  18588
Open to new sites?  No
Recruitment start date: 15-Apr-2015
Recruitment end date: 30-Apr-2019
CRCTU Trial Management Team: Supportive Care
Trial E-mail Address: 

More information

Please note: Clinical trial protocols are complex technical documents, which should only be used for the treatment of subjects taking part in the trial.  Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to CancerHelp website (see the link below)