
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at a drug called folic acid to help manage hot flushes in women who have been through the menopause. It is for women who have had breast cancer, a type of womb cancer called endometrial cancer or women who don’t have cancer.
Hot flushes are a common symptom of . They are caused by a fall in the amount of a female hormone called oestrogen. Doctors usually treat hot flushes in post menopausal women with drugs called hormone replacement therapy (
). Cancer treatment can cause women to go through the menopause earlier and their symptoms may be worse. There is also the risk that HRT could cause breast or womb cancer to come back. So doctors are looking at other ways to manage hot flushes in this group of women.
In this trial, they are looking at . They are not sure yet how well this will work so they want to find out more. They will also collect blood and urine samples to see what happens to folic acid in the body.
The aims of the trial are find out if folic acid helps to control hot flushes in women who have been through the menopause.
You may be able to join this study if all of the following apply. You
You cannot join this study if any of these apply
The study team need 236 women to take part. This is a phase 3 study. It is randomised. The women taking part are put into treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind study.
Folic acid is a tablet. You take 1 folic acid or dummy tablet every day for 3 months.
You will also have a blood and urine test when you start and finish treatment.
The study team will ask you to fill in a questionnaire. The questionnaire will ask about other menopausal symptoms you are having and how you’ve been feeling. This is called a quality of life study. You complete these 4 times during the study.
Before you start the study you will see the doctor and have some tests. These include
You have a trial assessment once a month for a check up while you are having treatment. There is an option to have some assessments by phone instead of visiting hospital. But the first and last assessments must be done in hospital. Each assessment takes about an hour.
The side effects of folic acid are minimal. The possible side effects may include an allergic reaction and rarely, a mild stomach upset.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Mr Ayman Ewies
NIHR Clinical Research Network: Cancer
Sandwell and West Birmingham Hospitals NHS Trust
University of Birmingham
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.