Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk
NCT: NCT07187726 · RECRUITING
Brief 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
Frequently Asked Questions
What is Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk?
Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk is a clinical trial registered under NCT07187726. Current status: RECRUITING.
What is the status of NCT07187726?
The current status of NCT07187726 (Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk) is: RECRUITING.
When did Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk start?
Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk started on 2025-10-07.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.