Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07187726

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

Led by UNICANCER · Updated on 2025-11-18

724

Participants Needed

12

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before study procedures
  • Women aged 18 years or older
  • Unilateral invasive breast cancer cT1-4, cN0-N3, M0 treated with mastectomy or breast conservation surgery with negative margins
  • Axillary lymph node staging completed to define need for regional nodal irradiation
  • ECOG performance status between 0 and 2
  • Randomized within recommended time after last surgery or chemotherapy to avoid delaying radiotherapy
  • Women able to use contraception during and for 3 months after radiotherapy if of childbearing potential
  • Willing and able to comply with study treatment, visits, and follow-up
  • Affiliated with local social security or health system
Not Eligible

You will not qualify if you...

  • Previous breast cancer or ductal carcinoma in situ in the same breast
  • Bilateral breast cancer
  • Previous non-breast cancer unless disease-free over 5 years or low recurrence risk (except some in situ cancers and skin cancers)
  • Indication for boost radiation to regional lymph nodes
  • Prior radiation therapy to chest region
  • Existing arm swelling requiring compression sleeve at baseline
  • Medical conditions preventing compression sleeve use for 8 hours daily from radiotherapy start until 3 months after
  • Pregnant or breastfeeding women
  • Participation in another radiotherapy or lymphedema risk study
  • Person deprived of liberty or under guardianship
  • Psychological, social, or geographic issues that may hinder study compliance or follow-up

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Centre Marie Curie

Arras, France

Actively Recruiting

2

Centre Pierre Curie

Beuvry, France

Actively Recruiting

3

Clinique Tivoli Ducos

Bordeaux, France

Actively Recruiting

4

ROC 37

Chambray-lès-Tours, France

Actively Recruiting

5

CHI Créteil

Créteil, France

Actively Recruiting

6

Centre Georges François Leclerc

Dijon, France

Actively Recruiting

7

Centre Guillaume Le Conquérant

Le Havre, France

Actively Recruiting

8

Centre Antoine Lacassagne

Nice, France

Actively Recruiting

9

Institut Godinot

Reims, France

Actively Recruiting

10

ICO Nantes Saint Herblain

Saint-Herblain, France

Actively Recruiting

11

Institut de Cancérologie Strasbourg Europe

Strasbourg, France

Actively Recruiting

12

Gustave Roussy

Villejuif, France

Actively Recruiting

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Research Team

M

Marie Bergeaud, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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