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AuthorisedTherapeutic use (Phase IV)Interventional

Impact of EXercise on quality of life of early breast cancer patients on treatment with adjuvant Aromatase Inhibitors with or without CDK4/6 inhibitors. "The EX-AI study"

This study, called "The EX-AI study," is for women with early breast cancer who are currently receiving hormone treatments. Some of these women might also be taking another type of medicine known as a CDK4/6 inhibitor. The main goal is to understand how exercise can impact their quality of life, especially regarding symptoms often linked to hormone therapy. Researchers will look at changes in overall well-being, how much pain, tiredness, or other side effects they experience, and even things like body changes and sexual health. By taking part, women could help doctors learn more about how exercise can support patients during breast cancer treatment.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Fundacion Grupo Espanol De Investigacion En Cancer De Mama
Enrolment target
74
Start
29 Dec 2025

What is this study about?

This study, called "The EX-AI study," is designed for women who have been diagnosed with early breast cancer. These women are currently undergoing a common type of treatment known as hormone therapy. This therapy aims to prevent the cancer from coming back. Sometimes, another medicine called a CDK4/6 inhibitor is also given alongside hormone therapy to increase its effectiveness. The study wants to find out if adding exercise to their routine can make a real difference to how these women feel.

The main focus of this research is to see if exercise helps improve what doctors call "quality of life." This isn't just about feeling physically better; it also includes emotional well-being, dealing with treatment side effects, and generally feeling good about life. Specifically, the study will look at symptoms related to the hormone treatment, such as hot flashes, joint pain, or tiredness, and see if exercise can help reduce these.

The reason this study matters is that while hormone therapies are very important for treating breast cancer, they can sometimes cause side effects that impact daily life. If exercise can help manage these side effects and improve overall well-being, it could be a simple yet powerful way for patients to feel better during and after their treatment. The information gathered from this study could help doctors give better advice to future patients about how to live well while undergoing breast cancer treatment.

Key takeaways

  • Targets women with early breast cancer on hormone therapy.
  • Investigates if exercise improves quality of life during treatment.
  • Compares well-being, symptoms, and body changes.
  • Involves exercise, questionnaires, and regular health checks.
  • Aims to help doctors advise future patients on supportive care.

Who may be eligible?

This study is looking for women aged 18 years or older. There is no upper age limit for taking part.

You would be considered for this study if you have been diagnosed with early breast cancer. You must also be currently receiving specific types of hormone therapy, which might include medicines like Femara, Arimidex, Aromasil, Zoladex, Lutrate Depot, or similar treatments. Some participants might also be taking other medicines called CDK4/6 inhibitors, such as Verzenios or Kisqali.

More detailed checks would be done by the study team to make sure it's safe and appropriate for you to participate, but generally, it's for adult women with early breast cancer on these particular treatments.

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. Are you a woman aged 18 or older?
  2. Do you have early breast cancer?
  3. Are you currently taking hormone therapy medicines (like Femara, Arimidex, Aromasil, Zoladex, Lutrate Depot, etc.)?
  4. Are you also taking or considering taking a CDK4/6 inhibitor (like Verzenios or Kisqali)?
  5. Are you able to participate in a structured exercise program?
Answer every question to see your result.

What does participation involve?

If you join this study, your participation will involve several aspects. You will be asked to complete questionnaires that help measure your quality of life, pain levels, and how tired you feel. These questionnaires will be filled out at the start of the study and at different points throughout. You might also have assessments where your body composition is measured, including things like weight and muscle mass, using a special scale.

The study also involves an exercise program. Your commitment to this exercise will be recorded, likely through a virtual training platform and by exercise professionals. Researchers will also keep track of your medication, perhaps by counting pills and asking you to keep a diary.

Throughout the study, there will be standard clinical check-ups and blood tests to monitor your health and any side effects. The total duration of your participation will depend on the treatment schedule, but these types of studies typically involve regular check-ins over several months.

Potential risks and benefits

Participating in this study might offer several potential benefits. You could receive support and guidance for incorporating exercise into your routine, which may help manage some treatment side effects and improve your overall well-being. Your contribution will also help doctors better understand how exercise can support women going through breast cancer treatment. As with any study, there could be some risks, such as potential discomfort or injury from exercise, or the inconvenience of extra appointments and questionnaires. However, the study team will monitor you closely, and any side effects from treatments will be carefully watched. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What kind of exercise will I be doing?

The study will involve a structured exercise program, and your commitment to this will be monitored, likely through a virtual platform.

Will my regular breast cancer treatment change?

No, your existing breast cancer hormone treatment will continue as prescribed by your doctor. This study focuses on adding exercise.

How often will I need to visit the clinic?

You will have appointments at the start and at different times throughout the study to complete questionnaires and have some health checks.

What happens if I feel unwell during the study?

Your health will be monitored, and any side effects will be carefully recorded. You can discuss any concerns with the study team at any time.

Will I have to pay for anything?

You will not have to pay for any study-related medications or assessments. Always clarify with the study team about any potential travel costs.

How to find out more

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

Discussion

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