Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk
This research wants to find out if knowing your personal risk of arm swelling, called lymphedema, after breast cancer radiotherapy can help you and your doctors make better treatment decisions. Lymphedema can cause long-term discomfort and affect your quality of life, so understanding the risk is important. The study uses a special Artificial Intelligence (AI) tool that predicts your individual risk of arm swelling. This risk is shown on a simple website, which also explains what might increase your risk and suggests ways to reduce it, like wearing a compression sleeve. Participants will be split into two groups. One group will see their AI-predicted risk, while the other won't. Everyone will receive the same standard radiotherapy treatment. We'll follow you for two years to see how this information affects decisions, side effects, and overall well-being.
At a glance
What is this study about?
When you have radiotherapy after breast cancer surgery, there's a chance you might develop arm swelling, which doctors call lymphedema. This can be uncomfortable and affect your day-to-day life for a long time. This study aims to explore whether a new computer tool, using Artificial Intelligence (AI), can help in managing this risk better. The AI tool is designed to look at your individual details and estimate your personal chance of getting arm swelling.
The main idea behind this study is to see if knowing your specific risk of arm swelling, and having that information shared with your doctors, changes how treatment decisions are made and if it leads to better outcomes. The AI tool would present your risk on a simple website, explaining the factors involved and suggesting things you can do to lower your risk, like wearing a special compression sleeve on your arm.
Taking part in this study means you'll be put into one of two groups by chance. One group will be shown their personal arm swelling risk predicted by the AI tool, and this information will be used to guide discussions with your doctor. The other group will not see this predicted risk. Importantly, the actual radiotherapy treatment you receive will be exactly the same as what you would have had anyway. The only difference is whether or not you and your doctor are given this extra information about your risk of arm swelling. We will follow everyone for two years to gather information.
Key takeaways
- The study explores if knowing your personal arm swelling risk helps after breast cancer radiotherapy.
- A special AI tool calculates your risk, shown on a simple website.
- You'll get standard radiotherapy; the only difference is whether you see the AI risk.
- Participation involves monitoring for two years after treatment.
- The goal is to improve treatment decisions and potentially reduce arm swelling.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
This study is looking for women aged 18 or older who have invasive breast cancer that has not spread widely in the body (cT1-4, cN0-N3, M0). You would need to have had surgery like a mastectomy or breast-conserving surgery, and your doctors must have recommended radiotherapy to the lymph nodes in your armpit area. It doesn't matter what your hormone receptor status, tumor grade, or HER2 status is.
You can't have had breast cancer in the same breast before, or have bilateral breast cancer (cancer in both breasts). You also can't have had another type of cancer in the last five years, unless it was a very low-risk type that is completely gone.
To join, you must be willing to sign a consent form, able to attend appointments, and, if you could still get pregnant, agree to use reliable birth control during the study and for three months after your radiotherapy finishes. You also need to start the study within the recommended timeframe after your last surgery or chemotherapy.
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 breast cancer that requires radiotherapy to your lymph nodes?
- Have you not had breast cancer in the same breast before, or cancer in both breasts?
- Are you able to attend appointments for two years?
- If you could get pregnant, are you willing to use reliable contraception during the study?
What does participation involve?
If you decide to take part, you'll first sign a consent form. Then, by chance, you'll be placed into one of two groups. In one group, you and your doctor will see your personal risk of arm swelling, as predicted by an AI tool, on a website. This information might help guide your treatment choices, though your radiotherapy itself will be the same as standard care.
The other group will not be shown this predicted risk. Regardless of your group, you'll receive your radiotherapy treatment exactly as planned, just as you would outside the study. The main difference in your experience will be whether or not you are informed of the AI-predicted risk of developing arm swelling. After your radiotherapy, you will be followed for two years. During this time, the study team will monitor for any side effects, including arm swelling, and check your overall well-being and how well the AI tool is working. They will also note if you use a compression sleeve and track your quality of life, as well as how well the treatment is keeping the cancer away.
Potential risks and benefits
Locations (27)
- Centre Marie CurieVerified postcodeArras, France· Recruiting
- Centre Pierre CurieVerified postcodeBeuvry, France· Recruiting
- Clinique Tivoli DucosVerified postcodeBordeaux, France· Recruiting
- Centre François BaclesseVerified postcodeCaen, France· Recruiting
- ROC 37Verified postcodeChambray-lès-Tours, France· Recruiting
- Centre Jean PerrinVerified postcodeClermont-Ferrand, France· Recruiting
- CHI CréteilVerified postcodeCréteil, France· Recruiting
- Centre Léonard de VinciVerified postcodeDechy, France· Recruiting
- Centre Georges François LeclercVerified postcodeDijon, France· Recruiting
- CHD VendéeVerified postcodeLa Roche-sur-Yon, France· Recruiting
- Centre Guillaume Le ConquérantVerified postcodeLe Havre, France· Recruiting
- Clinique Victor HugoVerified postcodeLe Mans, France· Recruiting
Common questions
What is lymphedema?
Lymphedema is a type of swelling, in this case, in your arm, that can happen after breast cancer treatment, especially surgery and radiotherapy that affects your lymph nodes. It can cause discomfort and affect how you use your arm.
What is an AI tool?
AI stands for Artificial Intelligence. It's a computer program designed to learn from information and make predictions. In this study, the AI tool predicts your personal risk of developing arm swelling.
Will my radiotherapy treatment be different if I join?
No, your radiotherapy treatment will be exactly the same as if you weren't in the study. The only difference is whether you and your doctor see the AI-predicted risk of arm swelling.
How long will I be involved in the study?
You'll be followed for two years after your radiotherapy treatment starts. This allows researchers to see the long-term effects and how well the AI tool predicts outcomes.
Can I leave the study if I change my mind?
Yes, you are completely free to withdraw from the study at any time, for any reason, and it will not affect your ongoing medical care.
How to find out more
Marie Bergeaud, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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