Not yet recruitingNAINTERVENTIONAL

Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment

This study is investigating if a special type of exercise, called high-intensity interval training, can help women diagnosed with triple-negative breast cancer. This is a form of breast cancer that can be more aggressive. Participants will ride a special exercise bike during short bursts of intense activity, followed by rest periods. The researchers want to find out if this exercise can boost the immune system and make chemotherapy and immunotherapy more effective. This could potentially lead to a better response to treatment, meaning the cancer might shrink more, which is a good sign for recovery. The study aims to look at how exercising affects the body's fight against cancer and the overall success of current treatments.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital of Cologne

Enrolment target

Start

01 Sep 2024

Estimated completion

31 Dec 2027

Breast Cancer Triple Negative Breast Cancer

What is this study about?

This research study is for women who have been diagnosed with triple-negative breast cancer. This is a type of breast cancer that unfortunately can be more aggressive and make up about 15-20% of all breast cancer cases. Doctors are always looking for ways to make treatments work better for this type of cancer, and this study explores a new approach.

The main idea behind this study is to see if a specific type of exercise, called high-intensity interval training (HIIT), can help improve the effectiveness of your cancer treatments. HIIT involves short periods of intense exercise, like cycling really fast on a special bike, followed by short rest periods. Scientists believe that this kind of exercise might help by boosting your immune system, which is your body's natural defense against illness. A stronger immune system could potentially work better with your cancer medications.

Researchers also think that this exercise might improve blood flow to the cancer cells. Better blood flow could mean that the chemotherapy and immunotherapy drugs reach the cancer more effectively, leading to a better treatment response and potentially more positive outcomes. Essentially, this study is trying to understand if adding a specific exercise routine to standard cancer treatment can make a significant positive difference in how well the treatment works and how your body responds.

Key takeaways

Looks at how intense exercise (HIIT) might help women with triple-negative breast cancer.
Aims to see if exercise can boost the immune system and make cancer treatment more effective.
Participants will be randomly put into either an exercise group or a standard treatment-only group.
Could lead to better treatment outcomes and overall fitness.
Certain health conditions would prevent participation for safety reasons.

Who may be eligible?

To join this study, you need to be a woman who has been recently diagnosed with triple-negative breast cancer that can be seen on an ultrasound scan. Your doctors must also agree that the planned chemotherapy and immunotherapy treatments are suitable for you, and your cancer is not too advanced. You also need to be well enough to complete the study, with a life expectancy of at least three months.

There are also some important reasons why you might not be able to join. For example, if you've had other cancers recently (within the last two years, excluding minor skin cancers or early cervical cancer) or if you've already had systemic treatment for triple-negative breast cancer, you wouldn't be able to participate. Also, if you have certain health conditions that would make exercise unsafe, such as severe heart failure, serious breathing problems, or blood clotting issues, then this study wouldn't be suitable for you.

If you're able to have children, you'll need to agree to use effective contraception during the study and for a period after your last treatment. You also need to be able to speak German to participate. The study is open to women between 18 and 85 years old.

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 a woman diagnosed with triple-negative breast cancer?
Has your doctor agreed that you are suitable for the planned chemotherapy and immunotherapy?
Do you have any severe heart, lung, or blood clotting conditions that would make exercise unsafe?
Have you had any other cancers in the last two years (excluding minor skin cancers/early cervical cancer)?
Are you between 18 and 85 years old?
Are you able to speak German?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups. One group will receive the standard cancer treatment, and the other group will receive the standard cancer treatment plus the high-intensity interval training (HIIT).

The HIIT exercise involves using a special exercise bike (cycle-ergometer). The study will look at how this exercise affects your immune system response and how well your cancer responds to treatment. Researchers will compare the results between the group that exercises and the group that doesn't, to see if the exercise has a positive effect. They will also assess important health markers throughout the study. The total duration of your participation would depend on your treatment schedule and follow-up assessments.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. For this study, potential benefits might include a potentially better response to your cancer treatment and improved overall fitness if you are in the exercise group. However, we don't know for sure if the exercise will have these benefits. Potential risks related to the exercise could include muscle soreness, fatigue, or in rare cases, more serious issues like heart strain, especially if you have an underlying condition (though participants with such conditions are excluded). You always have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

University Hospital of Cologne and St. Elizabeth Hospital
Verified postcode
Cologne, Germany

Common questions

What is triple-negative breast cancer?

It's a type of breast cancer that doesn't have certain features that doctors usually target with specific medicines. It can sometimes be more aggressive.

What is high-intensity interval training (HIIT)?

It's a type of exercise that involves short bursts of intense activity, like cycling hard, followed by brief rest periods.

Will I definitely receive the exercise program if I join?

No, you will be randomly assigned to either receive the exercise program along with your treatment, or just receive your standard treatment.

How long will the study last for me?

The exact duration will depend on your specific treatment plan and how long follow-up assessments are needed.

Who is paying for this study?

The information provided doesn't specify the funding source for this trial.

How to find out more

Freerk T Baumann, PhD

freerk.baumann@uk-koeln.de 0221-478-42649 Official trial record

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