A study looking at diet and exercise during chemotherapy for breast cancer that has spread (B-AHEAD 3)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 2

This study is looking at a diet and exercise programme for women having chemotherapy for breast cancer. It is for women whose breast cancer has spread into surrounding tissues or to another part of the body. The study was developed by the researchers following on from the B-AHEAD 2 study.

More about this trial

Of the women having chemotherapy for breast cancer, many are above their ideal weight. The levels of fat in their body make up are higher and they often have a reduced muscle mass. Many women tend to gain more weight during chemotherapy and lose muscle mass. This may affect how chemotherapy works and the side effects that people experience.

In this study, researchers are looking at a diet and exercise programme to help women manage their weight during chemotherapy and maintain or increase their muscle mass. Some women take part in a diet and exercise programme and the other women take part in an exercise programme.

The aims of the study are to find out

If there are any differences in side effects from chemotherapy between the 2 groups
If there are any differences in amount of body fat and muscle between the 2 groups
More about how diet and exercise affects quality of life

Who can enter

You may be able to join this study if you are being treated at one of the recruiting hospitals, and all of the following apply.

You have breast cancer that has spread into tissue surrounding your breast (locally advanced), or has spread to another part of your body
You can’t have surgery to remove your cancer
You are due to be treated with chemotherapy
You have a body mass index (BMI) of 24 or more
You would like to lose weight
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are at least 18 years old

You cannot join this study if any of these apply.

You have cancer that has spread to your brain or spinal cord and is causing symptoms (you may still be able to take part if the cancer spread to your brain was treated at least 8 weeks ago and is not causing symptoms)
You have serious problems with your digestive system
You have diabetes and are having insulin
You take medication that affects the muscle mass in your body such as long term steroids (you may still be able to take part if you are having short term steroid treatment for less than 4 weeks)
Your cancer has spread to your bones and there is a risk you might get fractures or you can’t do resistance exercises because of pain (you may still be able to join if you have cancer in your bones but they are not at high risk of fracture)
You are having any other treatment as part of a clinical trial
You have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial

Trial design

The researchers need 134 women to take part in the study. It is randomised. The women taking part are put into 1 of 2 groups by computer. Neither you nor your doctor will be able to decide which group you are in.

Women in one group take part in a diet and exercise programme
Women in the other group take part in an exercise programme

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If you are in the diet and exercise group, you have an individual session with a dietitian Open a glossary item . They will talk to you about the food you like to eat and give you advice on how to follow a calorie restricted diet.

Women in both groups have an individual session with a physiotherapist or exercise specialist. They will teach you how to do some resistance exercises. Resistance exercise is also known as strength training. These exercises increase muscle strength and mass. Everyone will start doing the exercises 2 days before beginning chemotherapy. You do the exercises 3 times a week at home. This should take about 30 minutes each time.

Before you start treatment, you keep a food diary for up to a week. You record everything you eat and drink during this period.

The study team will ask you to fill in some questionnaires before you start the programme. The questionnaires will ask about your level of activity and how you’ve been feeling. This is called a quality of life study.

You will follow your programme while you are having chemotherapy. The researchers will phone you every 3 weeks to check how you are getting on and to provide further advice and support if necessary.

The study team will ask women in the diet group to keep a record of what they eat each week. Women in both groups will record how many sessions of resistance exercises they do and how difficult they find them.

During chemotherapy, you have routine CT scans around every 9 weeks. The study team will look at these scans to work out your muscle mass and body fat percentage.

The study team are also running a sub study alongside the main study. They may ask you if you would like to take part, but you don’t have to agree to this if you don’t want to. The sub study is looking at how diet and exercise affect insulin levels and other hormones in the blood. If you agree to take part, you give 2 extra blood samples at your local hospital 7 weeks after you start chemotherapy.

Hospital visits

You will see the study team and have some tests and assessments before starting the programme. These include

Blood tests
Testing your muscle strength

If you are able to visit the main study team at The Nightingale Centre in Manchester, the team will also

Weigh you and look at your percentage of body fat using special scales
Measure your waist and hips

Some of the above will be repeated 7 weeks after you start chemotherapy and then about every 6 weeks for as long as you are having treatment.

You will see a member of the study team when you go to the hospital to have your chemotherapy. If you choose not to go to the Nightingale Centre at the start of the study, you won't have any extra hospital visits.

Side effects

Having chemotherapy can be a difficult time, so you may be disappointed if you aren’t able to stick to the diet and exercise plan completely. You may also find some of the questions in the questionnaires upsetting. If you need someone to talk to about how you are feeling, you can talk to a member of the study team or they can refer you to a breast care nurse or psychologist.