“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A study looking at healthy eating and exercise in women having chemotherapy for breast cancer (B-AHEAD 2)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Of the women diagnosed with breast cancer each year, many will be above their ideal weight, and many expect to lose weight during chemotherapy. However, the majority of women will put weight on during treatment. This is because chemotherapy reduces the amount of energy from food that your body needs, but can also increase your appetite.
There is evidence to show that preventing weight gain, being a healthy weight and taking regular exercise can reduce the risk of your cancer coming back. Keeping a healthy weight may also improve your wellbeing after diagnosis.
Researchers in this study are trying to find the best way to control weight in women having chemotherapy. Their previous study, B-AHEAD, looked at diet and exercise after surgery for breast cancer. It showed that those having chemotherapy had more problems with weight control. So they have developed a diet that may help this group, where you follow a diet for 2 days a week instead of everyday. So, half the women in B-AHEAD 2 will eat a low
Who can enter
You may be able to enter this study if
- You have breast cancer and are due to have chemotherapy
- You live in the Greater Manchester or Cheshire area, or you would be willing to travel from outside this area to take part
- Your cancer has not spread to another part of your body – it may have spread to nearby lymph nodes when you were diagnosed
- You are not underweight (you have a
body mass index (BMI)of 19 or more)
- You have satisfactory blood test results
- You are able to read and understand written instructions
- You are at least 18 years old
This study will recruit 170 women. It is randomised. The women taking part are put into one of 2 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 follow a diet that is low in carbohydrates for just 2 days a week, and a healthy diet for the rest of each week. If you are in group 2, you follow a calorie controlled healthy eating diet every day. Both groups follow their plan throughout their whole course of chemotherapy.
Women in both groups will try to exercise for 30 minutes, 5 days a week. You have specialist advice and support for how to eat and exercise
- At the start of the study
- Through phone calls every 2 weeks
- Through information sheets posted to you
You come to hospital twice during the study. You will have an assessment of your weight and body fat using a scan called a
- Have your waist and hips measured
- Have your blood pressure measured
- Give a blood sample (about 4 teaspoons)
- Complete a short fitness test on a treadmill
You also fill out some questionnaires about your health and how you have been feeling. These appointments will take about 2 hours.
For 7 days before each appointment and for 3 weeks in the middle of your course of chemotherapy, you complete a diary recording the food you eat. The team will also ask you to wear a small monitor on a belt around your waist for these 3 weeks, to see how active you are. And, to fill out questionnaires asking about any tiredness (fatigue).
The team are also running 3 sub studies within this 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 first sub study is looking at how diet affects 2
The second sub study is looking at the short and long term effects of dieting 2 days a week (group 1). You give a blood sample straight after your 2 diet days, on the morning of your last chemotherapy. This sample is collected at the same time as your routine blood samples. You can’t eat or drink before this test.
The third sub study is asking whether you found this programme easy or hard to follow. You either join a discussion group or have an interview after the study.
At the end of the study a dietician and exercise specialist will give you personal advice about how you can maintain your weight or lose more, if you would like to.
You visit the hospital for your assessments before you start chemotherapy and 3 weeks after your final dose.
You will be exposed to a small amount of radiation from the study DXA scans. We are all exposed to a very small amount of radiation during the course of a normal day (background radiation). The amount of radiation you get from the scans is the same as about one day of background radiation.
How to join a clinical trial
Dr Michelle Harvie
Breast Cancer Research Trust
NIHR Clinical Research Network: Cancer
University Hospital of South Manchester (UHSM)