“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A trial looking at cognitive behavioural therapy to reduce the impact of hot flushes and night sweats (MENOS 4)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for women with primary breast cancer who have completed surgery and either radiotherapy or chemotherapy or both. They must have 7 or more hot flushes (flashes) or night sweats a week and rate these as problematic.
More about this trial
7 out of 10 women (70%) who have had treatment for breast cancer have hot flushes and night sweats. And these can have a negative impact on daily life and ability to sleep.
There are drug treatments that can help but these can have unpleasant side effects.
A number of research studies have shown that a talking therapy called
In this trial, breast care nurses are trained in CBT. The researchers want to find out if the nurses can deliver a similar reduction in the impact of hot flushes and night sweats for women who have had treatment for breast cancer.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
- Have primary breast cancer or ductal carcinoma in situ (DCIS)
- Have completed your first (primary) treatment for your breast cancer, surgery and either radiotherapy or chemotherapy or both. You can take part if you are still taking hormone therapy or are having trastuzumab (Herceptin)
- Are having 7 or more hot flushes or night sweats a week and you rate these as problematic
- Are 16 years or older
You cannot join this trial if any of these apply. You
- Have breast cancer that has spread elsewhere in your body (secondary breast cancer)
- Have a non cancerous (benign) breast disease
- Are currently using complementary therapies to do with your mind and body to help with your hot flushes and night sweats such as acupuncture and mindfulness. You might still be able to take part if you’re taking herbal remedies or medication
This is a randomised trial. The researchers would like between 120 to 160 women to take part.
Firstly the researchers will ask some questions about how often you have hot flushes and night sweats and how much they affect your daily life. This is to make sure you are able to take part in the trial.
If you are suitable, the researchers take your details. They will get in touch with you when they have enough women to form a therapy group at, or near, your local hospital.
Everyone taking is put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- One group have nurse led group cognitive behavioural therapy (CBT)
- The other group have usual NHS care
You have 6 therapy sessions, once a week at your local hospital or somewhere nearby. The session lasts about 90 minutes and is led by a breast care nurse following a CBT manual.
To check the quality of the sessions they are recorded by the trial team.
Some people in the CBT group will be asked to have a face to face interview with one of the trial team. They want to ask some questions about the CBT and whether there was anything not covered in the questionnaires used in the trial.
Usual NHS care
You don’t attend the therapy sessions. But at the end of the trial you are offered a booklet and CD that includes the same information people in the CBT group had. You can have a one to one meeting with a breast care nurse to go through the main parts of the booklet. The team also phone you on 2 occasions to see how you are getting on and ask about any problems you might be having with the CBT.
Everyone taking part is asked to complete some questionnaires at:
- the beginning of the trial
- 9 and 26 weeks after starting in the trial
These ask questions about your:
- hot flushes and night sweats
quality of life
- general health
You are also be asked to keep a diary record of how many hot flushes you have over a number of days and how much these bother you.
If you are in the group having CBT you need to attend your therapy session once a week for 6 weeks.
If you are having usual NHS care and you accept the booklet and CD at the end of the trial, if you want, you can have one visit with a breast care nurse.
You are not expected to have any negative side effects from taking part in this trial.
How to join a clinical trial
Professor Deborah Fenlon
Breast Cancer Now
Southampton Clinical Trials Unit
University of Southampton