RecruitingNAINTERVENTIONAL

Physical Exercise During Preoperative Chemotherapy for Breast Cancer

This study is investigating if exercise during chemotherapy for breast cancer can make the treatment more effective. Specifically, it wants to see if a structured exercise program helps to completely get rid of the cancer in the breast and lymph nodes before surgery. Researchers also want to understand if exercise improves how patients feel, their strength, fitness, and how well they cope with chemotherapy side effects like tiredness or memory issues. Approximately 700 patients will either follow a supervised exercise plan with an app or continue with their usual activities. The study will track their health and recovery for two years to see the long-term benefits.

At a glance

Status

Recruiting

Phase

Sponsor

Karolinska Institutet

Enrolment target

712

Start

09 Nov 2022

Estimated completion

01 Jun 2028

Breast Cancer

What is this study about?

This study, called Neo-ACT, is looking into how exercise during breast cancer treatment might help. Many women with breast cancer receive chemotherapy before surgery. This 'pre-surgery' chemotherapy aims to shrink the tumour and, in some cases, completely clear the cancer cells. When no cancer cells are found after this chemotherapy and surgery, it's called a 'pathological complete response' (pCR), which is a very good sign for recovery.

While we know exercise can help people feel better during tough treatments, scientists are especially keen to learn if exercise can actually help the chemotherapy work more effectively and improve overall chances of recovery. This study will compare a group of patients who follow a special exercise program during their chemotherapy with another group who continue with their normal routine. They will carefully check if the exercise group has higher rates of pCR.

Beyond simply checking if the cancer clears completely, the study will also look at many other things. This includes how exercise affects your quality of life, energy levels, muscle strength, fitness, and even how well you think and remember things during and after chemotherapy. Researchers also want to see if exercise reduces side effects or the number of sick days taken. By tracking these details, the study aims to understand how exercise might specifically help fight cancer and improve life for patients.

Key takeaways

The study explores if exercise during chemotherapy can improve breast cancer treatment outcomes.
It aims to see if exercise helps completely clear cancer cells before surgery.
Exercise might also improve well-being, strength, and reduce side effects during treatment.
Participants will either follow an exercise plan or continue with usual care.
The study lasts for two years and includes fitness, strength, and quality of life assessments.

Who may be eligible?

This study is for adults aged 18 or over who have been diagnosed with primary invasive breast cancer that hasn't spread widely. You'll need to have all your tumour information available before starting chemotherapy.

There are some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have another serious health condition (like certain heart problems, severe lung conditions, or bone and muscle issues) that would make it unsafe to exercise. Also, if you already do a lot of intense exercise regularly, you might not be suitable for this study.

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.

Are you 18 years old or older?
Have you been diagnosed with primary invasive breast cancer?
Are you currently pregnant or breastfeeding?
Do you have any serious health conditions that would make exercise unsafe?
Do you already exercise intensely for more than 150 minutes per week?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will last about two years. If you are in the exercise group, you'll do two hours of exercise each week, starting from when you begin chemotherapy until your surgery (roughly five months). This will be a mix of high-intensity interval training (short bursts of hard exercise followed by rest) and strength training, guided by a mobile app and supported by a local physiotherapist.

Your exercise plan will be tailored to your fitness level. Sessions will usually begin with a short warm-up. Regardless of which group you are in, the study will regularly check how your tumour is responding to treatment using scans. They will also ask you to fill in questionnaires about your quality of life and physical activity, and you'll have tests to check your muscle strength, fitness, and memory. Your physical activity will be carefully monitored using a special activity tracker.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as improved fitness, strength, and overall well-being during your chemotherapy. The exercise might also help to reduce some treatment side effects and potentially improve how well your body responds to the chemotherapy. However, there's no guarantee of direct benefit for every individual. Potential risks of exercise include muscle soreness, fatigue, or, in rare cases, injury, but the program is designed to be safe and tailored to your ability. Your health will be closely monitored. You are free to withdraw from the study at any time without affecting your medical care.

Locations (13)

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

Cabrini Health
Verified postcode
Melbourne, Australia· Not yet recruiting
Helsinki University Hospital
Verified postcode
Helsinki, Finland· Recruiting
Turku University Hospital
Verified postcode
Turku, Finland· Not yet recruiting
Karolinska University Hospital
Verified postcode
Stockholm, Sweden· Recruiting
Sahlgrenska University Hospital
Verified postcode
Gothenburg, Sweden· Recruiting
Skaraborgs sjukhus
Verified postcode
Lidköping, Sweden· Recruiting
Capio St Görans Hospital
Verified postcode
Stockholm, Sweden· Recruiting
Southern General Hospital
Verified postcode
Stockholm, Sweden· Recruiting
Sundsvall Hospital
Verified postcode
Sundsvall, Sweden· Recruiting
Umeå University Hospital
Verified postcode
Umeå, Sweden· Recruiting
Västmanlands Hospital
Verified postcode
Västerås, Sweden· Recruiting
Edinburgh Napier University
Verified postcode
Edinburgh, United Kingdom· Not yet recruiting

Common questions

What kind of exercise will I be doing?

You'll be doing a mix of high-intensity interval training and strength exercises, guided by an app and physiotherapists, tailored to your fitness.

How long will the study last for me?

If you join, you will be followed for a period of two years.

Will my regular doctors still be in charge of my care?

Yes, your medical team will continue to manage all your cancer treatment; the study focuses on adding exercise support.

What if I get too tired to exercise?

The exercise programme is flexible and can be adjusted by the physiotherapists if you feel unwell or too tired.

Do I have to pay for anything if I join?

No, all aspects of your participation in the study, including the exercise programme and assessments, are covered by the study.

How to find out more

Jana de Boniface

jana.de-boniface@ki.se +46702472305 Official trial record

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