“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 ovarian protection for premenopausal women having chemotherapy for breast cancer (OPTION)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is trying to find out if it is possible to protect the ovaries, and so prevent early menopause, in women having chemotherapy for breast cancer. This trial is supported by Cancer Research UK.
Doctors often treat breast cancer with chemotherapy. But chemotherapy damages the ovaries in up to 8 out of 10 women (80%) who have not been through the menopause (are premenopausal). This damage can cause premature menopause. This can be distressing, and can also lead to premature osteoporosis.
Goserelin (Zoladex) is a type of hormone therapy that usually stops the ovaries working. Doctors hope that if they can stop ovaries working while women have chemotherapy, the chemotherapy will be less likely to damage their ovaries. They hope that this will help to prevent premature menopause, but they are not sure yet how well this will work.
The aim of this trial is to see is goserelin can help prevent early menopause caused by chemotherapy.
Who can enter
You can enter this trial if you
- You have stage 1, 2 or 3 breast cancer
- Are due to have chemotherapy
- Have not been through the menopause
You cannot enter this trial if you
- Have stage 4 breast cancer that has spread to another part of your body
- Have had chemotherapy before
- Have had any other cancer in the past, apart from non melanoma skin cancer or carcinoma in situ of the cervix
- Are pregnant or breastfeeding
This is a randomised trial. It will recruit 250 women into 2 groups. The women taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1 you will have chemotherapy alone. The drugs you have will depend on your individual situation. Your doctor will talk to you about your treatment in more detail. You will have chemotherapy for between 4 and 6 months altogether.
If you are in group 2 you will have chemotherapy for about 4 to 6 months. You will also have goserelin (Zoladex) injections once every 4 weeks while you are having chemotherapy.
You will fill out a questionnaire before you start treatment and for up to 5 years afterwards. This will ask you how you have been feeling and about any side effects you have had. It is called a Quality of Life questionnaire.
You will see the doctors and have some tests before you can take part in this trial. These include
- Blood tests
- Chest X-ray
- Heart trace (ECG)
- Physical examination
You may also have a bone scan to check your bone density.
You will go to the hospital every 3 or 4 weeks for chemotherapy. Exactly how often you have treatment will depend on the combination of drugs your doctor decides is best for you. You are likely to have chemotherapy for between 4 and 6 months altogether.
If you are in group 2 you will have goserelin as an injection just under the skin once a month for as long as you have chemotherapy. This can be a bit sore, so you will have a local anaesthetic to numb the skin first.
After treatment you will see the doctors every 3 months for a year, every 6 months for another year, and then every year for 3 years.
Goserelin stops the ovaries working, so you will have some menopausal symptoms if you are in group 2. These include
- Hot flushes
- Mood changes
There is more information about goserelin (Zoladex) and on coping with menopausal symptoms on CancerHelp UK.
The side effects of chemotherapy will depend on the drugs you have. But the most common side effects of chemotherapy for breast cancer are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and shortness of breath
- Feeling or being sick
- Hair thinning or hair loss
There is information about the side effects of specific chemotherapy drugs on CancerHelp UK.
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.
Professor Rob Leonard
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/04/004.