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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
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
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
October 7, 2025
Primary Completion Date
January 31, 2029
Completion Date
January 31, 2029
Last Updated
November 18, 2025
724
ESTIMATED participants
XAINET AI tool
DEVICE
Lead Sponsor
UNICANCER
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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