A study of healthy eating and exercise in women who have an increased risk of breast cancer (The Family History Lifestyle Study)

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 3

This study is comparing 3 different weight loss programmes for women who have an increased risk of developing breast cancer.

The study is open to women who:

  • have a family history Open a glossary itemof breast cancer
  • are attending a family history clinic

More about this trial

Some people have a higher risk of developing breast cancer than the general population because other members of their family have had certain cancers. This is called a family history of cancer.

You usually attend a clinic if you have a  family history of breast cancer. At the clinic, the staff work out your individual risk of developing cancer. You then have regular mammograms Open a glossary item to monitor any changes in your breasts.

Being overweight and not having a healthy lifestyle can increase the risk of breast cancer and other diseases such as heart disease. We know from research that losing a bit of weight and keeping it off is linked to a lower risk of developing breast cancer. But family history breast cancer clinics don’t offer routine weight loss or lifestyle services.

In this study, researchers want to compare 3 weight loss programmes for women attending these clinics. Women have 1 of the following:

  • detailed written information on healthy eating and physical activity
  • detailed written information on healthy eating and physical activity and support from a dietician
  • detailed written information on healthy eating and physical activity, support from a dietician and information about developing other medical conditions linked to being overweight

The main aims of the study are to find out:

  • if women are willing to take part in a weight loss programme
  • how well the different programmes work to help women lose weight

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply.

You:

  • have a moderate to high risk of developing breast cancer
  • are having a mammogram every year to 18 months or are taking part in a screening programme because of your family history of breast cancer
  • have information about your risk of developing breast cancer
  • are overweight or obese with a body mass index (BMI Open a glossary item) of 25 or more
  • have access to the internet or a telephone
  • understand and can write in English
  • are willing to follow a diet and exercise plan

Who can’t take part

You cannot join this study if any of these apply.

Cancer related

You have had another cancer apart from basal cell skin cancer Open a glossary item or squamous cell skin cancer Open a glossary item that was successfully treated or precancerous cells on a cervical smear

Medical conditions

You:

  • have or have had a heart problem or blood vessel problem such as a heart attack, stroke, mini stroke, angina, heart failure or a blood vessel bulge (aneurysm)
  • take medication for high cholesterol
  • have diabetes
  • are taking certain medication to help with mental health problems such as clozapine or risperidone as these can cause weight gain
  • have a problem with drugs or alcohol
  • are already on a special medical diet that cannot be changed
  • are having treatment for weight loss, you have had stomach reduction surgery or you are planning to have this surgery in the next 12 months
  • have kidney disease
  • have a mental health problem that the study team think would affect you taking part

Other

  • another woman in your family is taking part in this study
  • you have an eating disorder such as binge eating or bulimia
  • you are already on a diet or a physical activity programme and you have lost more than 2 pounds or 1 kg in the last 2 weeks
  • you are pregnant, planning a pregnancy or breastfeeding

Trial design

This is a phase 3 trial. The researchers hope 209 women will take part.

It is a randomised trial. You are put into 1 of 3 groups by a computer. Neither you nor the researchers can decide which group you are in.

The 3 groups are:

  • group 1 – you have written information about physical activity and diet
  • group 2 – you have written information about diet and physical activity and support via the phone and email from a dietician
  • group 3 – you have written information about diet and physical activity, support via the phone and email from a dietician and information about other diseases linked to being overweight such as diabetes and heart disease

Everyone is encouraged to lose 1lb to 2lb (½ kg to 1 kg) a week.

Diet

The study team are recommending 2 diets. They are:

  • the 2 day diet – this is 2 days of low calorie Open a glossary item, low carbohydrate Open a glossary item food and 5 days of the healthy Mediterranean diet
  • the Mediterranean diet 7 days a week

Mediterranean healthy eating includes lower fat meats, fish, fruit, vegetables, wholegrains, beans, pulses and low fat dairy products.

The study team will give you a booklet on each diet and you can chose which diet you follow. Although they will recommend you try the 2 day diet first.

Physical activity

You aim to build up to 30 minutes of moderate to intense physical activity such as brisk walking for 5 days a week.

Research sub studies

There are 3 sub studies in this study. They are:

  • a study of mammograms Open a glossary item looking at breast density and any changes after weight loss
  • a study looking for proteins in the blood linked to breast cancer
  • an interview study to asking people’s views about this study and if the programmes helped them or not

The protein study involves having a blood test. You don’t have to agree to join any of these studies if you don’t want to. You can still join the main study.

Quality of life

The trial team will ask you to fill out paper or online questionnaires before you join the study and at set times during the study. The questionnaires will ask how you’ve been feeling. These are called quality of life questionnaires. Open a glossary item

There are also some other questionnaires that ask about your general health and your weight and diet history.

Hospital visits

You have 3 appointments at your local hospital. These are a visit:

  • to see if you are suitable to join the study
  • 6 months after joining the study
  • at 12 months

At each visit you have some assessments that include:

  • measuring your weight, height, body fat, waist, hips and bust
  • blood pressure
  • a finger prick blood test for women in group 3 to check cholesterol

Side effects

Some women might feel disappointed if they can’t lose the weight they hoped they would.

You might have a bit of pain, discomfort or a small bruise after having a blood test.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Michelle Harvie

Supported by

Manchester University NHS Foundation Trust

Prevent Breast Cancer Ltd

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15343

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

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