A trial looking at folic acid for women having postmenopausal symptoms (FOAM)

Cancer type:

Breast cancer
Womb (uterine or endometrial) cancer

Status:

Results

Phase:

Phase 3

This trial was done to find out if folic acid could help manage hot flushes in women who have been through the menopause. It was for women who had breast cancer or endometrial (womb) cancer, as well as women who didn’t have cancer.

This trial was open for people to join between 2015 and 2019. The team published the results in 2021.

More about this trial

Hot flushes are a common symptom of menopause. They are caused by a drop in the level of a female hormone called oestrogen. 

Doctors often treat hot flushes in post menopausal women with hormone replacement therapy (HRT). But they are looking at other ways to manage hot flushes in women who’ve had treatment for breast cancer. In this trial they were looking at folic acid.

The main aim of this trial was to find out if folic acid could help control hot flushes in women who have been through the menopause.

Summary of results

Trial design
This trial was for women who had been through the menopause and were having hot flushes. 

They were put into 1 of 2 treatment groups at random. Half took folic acid tablets every day for 3 months. And half took dummy (placebo) tablets every day for 3 months.

Results
A total of 164 women joined this trial. They were put into a treatment group:

  • 83 had folic acid tablets
  • 81 had dummy (placebo) tablets

The research team asked the women taking part how many hot flushes they were having before, during and after the trial. 

The number of hot flushes went down in both groups. It went down a little more for the people who had folic acid. But the difference wasn’t big enough to say for sure whether it was because of the folic acid. It may have been chance.

Conclusion
The research team concluded that they were unable to say whether folic acid tablets helped with hot flushes in women who’d been through the menopause.

They suggest a larger trial is done to find out more.

More detailed information
There is more information about this research in the reference below. 

Please note, this article is not in plain English. It has been written for health care professionals and researchers.

Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial
A Ewies and other
British Journal of Obstetrics and Gynaecology. Published online, May 2021.

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Ayman Ewies

Supported by

NIHR Clinical Research Network: Cancer
Sandwell and West Birmingham Hospitals NHS Trust
University of Birmingham

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12941

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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