“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
A trial looking at exercise and healthy eating for women with breast cancer (B-AHEAD)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial will compare 3 different ways of promoting a healthy lifestyle in women who have breast cancer.
About 75 out of every 100 women (75%) diagnosed with breast cancer put on weight during treatment, including women who were a normal healthy weight before their diagnosis. Many women would like advice about diet and exercise but at the moment very few women are given this information. The researchers say that there is increasing evidence that weight control and exercise may reduce the risk of the cancer coming back, reduce the risk of other health problems, and improve quality of life.
This trial will look at 3 different ways to control weight. Women will either have
- A healthy living booklet
- Individual advice on healthy eating and physical activity followed by support at home by letter and phone
- Individual advice on healthy eating and physical activity followed by weekly group exercise and dietary education classes
The results of each group will be compared to find out which way is better at helping women of a healthy weight to maintain their weight and overweight women to lose weight.
Who can enter
You can enter this trial if you
- Have stage 1, 2, or 3 breast cancer and you had surgery to remove it no more than 12 weeks ago
- Have had surgery or treatment for breast cancer at one of the hospitals in Greater Manchester or Cheshire that are involved in the trial
- Have either
in situ breast canceror invasive breast cancer
You cannot enter this trial if you
- Have breast cancer that cannot be removed with an operation, or has spread to another part of your body (stage 4 breast cancer)
- Had chemotherapy or hormone therapy before your surgery to remove your breast cancer (called
- Have any physical condition that would make it difficult for you to take part in this trial. For example, insulin controlled diabetes, inflammatory bowel disease, heart disease, breathing problems or joint problems which would prevent you taking exercise (the research nurse and physiotherapist will decide whether you are well enough to take part)
- Have any psychiatric condition that may affect your taking part. For example severe untreated depression or severe personality disorder
steroidtablets each day for another medical condition (you can take part if you take steroids for a few days when you have chemotherapy)
This phase 2 trial aims to recruit about 480 women who have had surgery for breast cancer. The trial is randomised. This means that women taking part are put into 1 of 3 different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. All women are encouraged to exercise and follow a healthy diet.
If you are in group 1, you will have a booklet about healthy living after breast cancer.
If you are in group 2 or 3, you will meet with the research dietitian and exercise specialist. They will give you advice about diet and exercise, based on your individual needs.
If you are in group 2, the researchers will telephone you and post information to your home every other week for 3 months. The phone calls will take about 20 minutes, they will check how you are getting on with your diet and exercise plan.
If you are in group 3, you will be invited to go to weekly group exercise and diet education sessions for 12 weeks. Each session takes about an hour and a half. The meetings will take place in a number of venues around Greater Manchester. You will also be encouraged to do exercise at home.
After 12 months, all women will meet individually with the dietitian and exercise specialist. The dietitian and exercise specialist will encourage you to continue with your personal diet and exercise plan.
Before you start this trial, you will have various tests and assessments including
- Blood tests
- Weight, body fat, waist and hip measurements
- Walking fitness test on a treadmill
You will also see a specialist breast cancer physiotherapist and complete a questionnaire about your ‘quality of life’. This appointment will take 2 and a half to 3 hours. You will complete a food and activity diary for 7 days to find out what you are eating and how active you are.
You will visit hospital to have these tests and assessments again 6 and 12 months later. You will also have appointments as part of your breast cancer treatment and follow up. You would have these whether you take part in this trial or not. Where possible, the trial team will try and arrange their appointments on days that you go to hospital for follow up appointments.
There are no risks associated with following the diet and exercise programmes as part of this trial. The recommended diet and exercises are known to be safe for women having breast cancer treatment. The diet will meet all your nutritional needs and the exercise specialist will make sure you are exercising at a safe level.
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.
Dr Michelle Harvie
Department of Health
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
The Genesis Appeal
University Hospital of South Manchester (UHSM)