RecruitingNot ApplicableNCT07187726

Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk

Multicenter Randomized Pivotal Stage Clinical Investigation Assessing the Communication of an Individualized AI-based Risk Prediction of Arm Lymphedema to Breast Cancer Patients With an Indication for Regional Lymph Node Irradiation and Their Physician as Part of Treatment Shared-decision


Sponsor

UNICANCER

Enrollment

724 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Radiotherapy after breast cancer surgery can lead to side effects like arm lymphedema (arm swelling). Lymphedema can cause long-term discomfort and affect quality of life. The goal of this clinical investigation is to determine whether using an artificial intelligence (AI) tool to predict the risk of developing arm lymphedema after breast cancer radiotherapy can help patients and physicians make better treatment decisions. This AI tool has been developed to determine each patient's personalized risk of developing lymphedema. The risk is shown using a web app that explains the factors involved and offers suggestions like using a compression sleeve to reduce the risk. Women (≥18 years) with breast cancer (cT1-4, cN0-N3, M0) requiring regional lymph node irradiation post-mastectomy or breast-conserving surgery are eligible, regardless of hormone receptor status, tumor grade, or HER2 status. Patients will be randomly divided into two groups: * Experimental group: Patients and physicians will see the AI-predicted risk and use it to guide treatment choices. * Control group: The risk is not shown. The radiotherapy treatment will be exactly the same as the treatment that you would have received if you had not taken part in this clinical investigation. The only intervention will be whether or not the risk you are informed of the risk of developing lymphedema. All patients will be followed for two years to monitor: * How risk communication influences radiotherapy treatment choices * The occurrence of side effects * The predictive performance of the AI tool * Patients' quality of life * Compliance with compression sleeve use * Loco-regional recurrence-free survival, distant disease-free survival, and overall survival


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether informing breast cancer patients of their AI-predicted personal risk of developing arm swelling (lymphedema) after radiation therapy to the lymph nodes changes how often arm swelling actually occurs or how patients cope with that risk. **You may be eligible if...** - You are a woman 18 or older with unilateral invasive breast cancer - You have had surgery (mastectomy or lumpectomy with clear margins) with or without chemotherapy - Lymph node staging confirmed the need for radiation to the lymph node areas - Your overall health is good (ECOG 0–2) **You may NOT be eligible if...** - You have a previous history of breast cancer or DCIS - You are pregnant or plan to become pregnant during radiotherapy - You cannot comply with scheduled visits and follow-up during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEXAINET AI tool

The AI-based prediction of arm lymphedema risk is communicated to the patient and treating physician.


Locations(12)

Centre Marie Curie

Arras, France

Centre Pierre Curie

Beuvry, France

Clinique Tivoli Ducos

Bordeaux, France

ROC 37

Chambray-lès-Tours, France

CHI Créteil

Créteil, France

Centre Georges François Leclerc

Dijon, France

Centre Guillaume Le Conquérant

Le Havre, France

Centre Antoine Lacassagne

Nice, France

Institut Godinot

Reims, France

ICO Nantes Saint Herblain

Saint-Herblain, France

Institut de Cancérologie Strasbourg Europe

Strasbourg, France

Gustave Roussy

Villejuif, France

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NCT07187726