All studies
CompletedInterventional

Breast activity and healthy eating after diagnosis 3

Chemotherapy is a common and important treatment for advanced breast cancer, but it can often cause people to gain body fat and lose muscle strength. This change in body composition may worsen side effects and make treatment harder to tolerate. The B-AHEAD 3 study investigates whether guided lifestyle changes can help. In this study, women receiving chemotherapy are split into two groups by chance. One group takes part in regular strength exercises, while the other does the same exercises alongside a specially designed, calorie-controlled healthy eating plan. Expert NHS dietitians and fitness specialists support both groups throughout their chemotherapy. Researchers will measure whether these programmes help patients stay stronger, protect their muscle, cope better with chemotherapy side effects, and improve overall well-being. Everyone receives personalised advice on nutrition and exercise by the end of the trial.

At a glance

Status
Completed
Sponsor
Manchester University NHS Foundation Trust
Enrolment target
134
Start
01 May 2015
Estimated completion
31 Mar 2021

What is this study about?

When having chemotherapy for advanced breast cancer, many women find that their weight and body shape change. It is very common to gain body fat while losing lean muscle tissue. Doctors know that having lower muscle stores and higher body fat can sometimes make chemotherapy side effects more severe and may affect how well treatments work. However, practical advice about diet and physical activity is not always offered as a standard part of cancer care.

The B-AHEAD 3 trial aims to find out if specific lifestyle programmes can support women during their chemotherapy. Researchers want to discover whether building muscle through strength training—either on its own or paired with a carefully planned, lower-calorie diet—can help women feel stronger, reduce fatigue, and manage their cancer treatment better. Strength exercises help keep bones and muscles robust, while healthy eating aims to prevent unwanted weight gain.

By taking part, participants help NHS teams learn how to design the best possible diet and exercise guidance for people facing cancer in the future. The trial is running across several NHS hospital trusts in England and is supported by experienced cancer care specialists.

Key takeaways

  • The study tests whether strength training and healthy eating help women cope better with chemotherapy.
  • It is open to women with advanced breast cancer who are starting chemotherapy and want to manage their weight.
  • Participants are supported by NHS cancer dietitians and fitness specialists throughout treatment.
  • You will do strength exercises three times a week, and some women will also follow a lower-calorie eating plan.
  • Taking part is voluntary, and you can leave the study at any time without your regular care changing.

Who may be eligible?

This study is designed for adult women aged 18 or older who have been diagnosed with advanced breast cancer (either locally advanced cancer that cannot be removed with surgery, or cancer that has spread to other parts of the body). You must be due to start a course of chemotherapy, or be within the first two weeks of your first cycle.

To take part, you should have a body mass index (BMI) of 24 or higher and want to lose weight in a safe, supported way. You should also be generally well enough to manage day-to-day activities with minimal help (a performance status of 0 or 1) and have an expected life outlook of at least three months.

You cannot join if you are already taking part in another clinical trial testing a new experimental medicine for this stage of your cancer. If you have had cancer spread to the brain, you may still be able to join if it has been treated with radiotherapy or surgery and has remained stable for at least eight weeks.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am a woman aged 18 or older.
  2. I have been diagnosed with advanced or metastatic breast cancer.
  3. I am about to start chemotherapy, or had my first treatment less than 15 days ago.
  4. My BMI is 24 or higher, and I would like to lose weight safely.
  5. I am up and about and able to carry out light daily activities.
  6. I am not currently taking part in a trial testing an experimental drug.
Answer every question to see your result.

What does participation involve?

Taking part happens alongside your regular chemotherapy appointments at the hospital. You will be placed into one of two groups by chance (like flipping a coin). One group does strength training exercises three times a week. The other group does the same strength exercises and also follows a tailored, calorie-reduced eating plan created by an expert cancer dietitian.

You will follow your programme for the duration of your chemotherapy treatment. A researcher will phone you every three weeks to check how you are getting on, answer questions, and offer encouragement. When you attend the hospital for your chemotherapy, a research nurse will check your weight, waist measurement, muscle mass, and any side effects you might be having.

You will also fill out questionnaires about your energy levels and quality of life. At the end of the study, every participant receives individual, professional guidance on healthy eating and exercise to take forward.

Potential risks and benefits

Taking part may help you stay stronger, keep your muscle mass, and prevent unwanted weight gain, which could make chemotherapy side effects easier to manage. You will also have regular contact with specialist diet and fitness experts. However, committing to regular exercise and changing what you eat can take extra time and effort, especially when you are already dealing with cancer treatment and tiredness. The diets and exercises are designed to be completely safe and provide all the nutrition you need. Joining is entirely voluntary, and you are free to stop participating at any time without it affecting your usual NHS medical care.

Locations (12)

  • The Nightingale Centre
    Approximate
    Manchester, England
  • The Christie NHS Foundation Trust
    City only
    Manchester, England
  • Leighton Hospital
    City only
    Crewe, England
  • The Royal Liverpool University Hospital
    City only
    Liverpool, England
  • Clatterbridge Hospital
    Approximate
    Wirral, England
  • Macclesfield District General Hospital
    Unverified
    Macclesfield, England
  • North Manchester General Hospital
    Unverified
    Manchester, England
  • Royal Oldham Hospital
    Unverified
    Oldham, England
  • Royal Stoke University Hospital
    Unverified
    Stoke-on-Trent, England
  • Tameside General Hospital
    Unverified
    Ashton-under-Lyne, England
  • Royal Albert Edward Infirmary
    Unverified
    Wigan, England
  • Royal Devon and Exeter Hospital
    Unverified
    Exeter, England

Common questions

What is strength or resistance exercise?

Strength exercise involves using light weights, resistance bands, or your own body weight to challenge your muscles. It helps keep your muscles and bones strong and firm.

Will I have to starve myself on the diet plan?

No. The eating plan is created by registered NHS cancer dietitians. It is designed to safely reduce calories while ensuring your body gets all the vitamins, minerals, and nutrients it needs during chemotherapy.

Can I choose which group I join?

No. A computer puts you into a group at random. This makes sure the study results are fair and reliable. Both groups receive expert support and exercise guidance.

Will this replace my usual cancer treatment?

No. The diet and exercise plans are done alongside your standard chemotherapy. Your cancer medicines and medical care remain exactly the same.

What happens if I feel too unwell to exercise?

Your health and comfort always come first. If you are having a tough day or feel very tired from chemotherapy, you can rest. The study team will help you adapt the activities to how you are feeling.

How to find out more

Michelle Harvie

Always speak to your GP or specialist before deciding to take part in a study.

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