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

NCT07187726 | Recruiting

• 1 other identifier: UC-RAD-2407
• Study Type: interventional
• Target: 724
• Locations: 2 countries
• Sites: 27

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

Conditions

Unilateral Breast Neoplasms

Keywords

Arm lymphedema; Individualized AI-based risk prediction

Outcome Measures

Primary Outcomes (1)

• Arm lymphedema

  Cumulative incidence of arm lymphedema on the treated side 2 years after adjuvant radiotherapy. The definition of arm lymphedema is ≥5% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side from baseline, compared to the contralateral side circumference and to its baseline value

  At 2 years

Secondary Outcomes (12)

• Impact of communicating the risk prediction for arm lymphedema on the choice of radiotherapy modality, fractionation, technique and nodal levels irradiated

  Up to 3 months from randomization.

• Acute and late toxicity during the study

  Throughout study completion, up to 2 years.

• Range of shoulder motion (ROM) of the arms

  Throughout study completion, up to 2 years.

• Breast cosmetic result

  Throughout study completion, up to 2 years.

• Performance of the arm lymphedema risk prediction model

  At 2 years

Study Arms (2)

Communication of the AI-based risk prediction to patient and physician.

EXPERIMENTAL

Device: XAINET AI tool

No communication of the AI-based risk prediction to patient and physician.

NO INTERVENTION

Interventions

XAINET AI tool DEVICE

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

Communication of the AI-based risk prediction to patient and physician.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 years
• Patients with unilateral invasive breast cancer, cT1-4, cN0-N3, M0 who had undergone radical surgery defined as mastectomy or breast conservation surgery with negative margins +/- (neo)-adjuvant systemic treatment. The patient can be included no matter the status of estrogen and progesterone receptors, malignancy grade, and HER2 status
• Axillary lymph node staging (by axillary dissection or sentinel lymph node biopsy and/or marked lymph node biopsy \[Marking Axillary lymph nodes with Radioactive Iodine seeds (MARI) procedure/ (Targeted Axillary Dissection (TAD) procedure\] in case of neo-adjuvant systemic treatment) defining the indication for regional nodal irradiation to levels I+/- II+/- III+/- IV+/- interpectoral nodes (Rotter) +/- the IMC(Internal Mammary Chain)
• ECOG performance status 0-2
• Patient must be randomized within the recommended time period from last surgery or the last series of chemotherapy whichever comes last as per national or institutional guidelines in order not to delay radiotherapy treatment start
• Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of radiotherapy
• Patient is willing and able to comply with the protocol for the duration of the clinical investigation including undergoing treatment and scheduled visits, and examinations including follow-up
• Patient affiliated to or a beneficiary of the local social security system, health service or other local regulatory requirements

You may not qualify if:

• Previous breast cancer or Ductal Carcinoma in Situ (DCIS) of the ipsilateral breast
• Bilateral breast cancer
• Patient with previous non-breast malignancy, with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
• Patient who has an indication for boost to one or more regional nodes
• Previous radiation therapy to the chest region
• Patients having arm swelling requiring arm sleeve prescription at baseline
• Any condition that prevents the patient from wearing a compression sleeve for 8h/day from the first day of radiation therapy until 3 months after the initiation of adjuvant radiotherapy
• Pregnant or breastfeeding women
• Patient already included in another therapeutic study involving radiotherapy dose/regimen/technique and/or arm lymphedema risk
• Person deprived of their liberty or under protective custody or guardianship
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (27)

Centre Marie Curie

Arras, France

RECRUITING

Centre Pierre Curie

Beuvry, France

RECRUITING

Clinique Tivoli Ducos

Bordeaux, France

RECRUITING

Centre François Baclesse

Caen, France

RECRUITING

ROC 37

Chambray-lès-Tours, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, France

RECRUITING

CHI Créteil

Créteil, France

RECRUITING

Centre Léonard de Vinci

Dechy, France

RECRUITING

Centre Georges François Leclerc

Dijon, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

Centre Guillaume Le Conquérant

Le Havre, France

RECRUITING

Clinique Victor Hugo

Le Mans, France

RECRUITING

Centre Oscar Lambret

Lille, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Centre de Radiothérapie de Seine-et-Marne

Melun, France

RECRUITING

Centre Antoine Lacassagne

Nice, France

RECRUITING

CH Lyon Sud

Oullins, France

RECRUITING

Institut Godinot

Reims, France

RECRUITING

Centre Henri Becquerel

Rouen, France

RECRUITING

ICO Nantes Saint Herblain

Saint-Herblain, France

RECRUITING

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, France

RECRUITING

CHU Sud La Réunion

Saint-Pierre, France

RECRUITING

CH de Saint Quentin

Saint-Quentin, France

RECRUITING

Centre Paul Strauss

Strasbourg, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

RECRUITING

Gustave Roussy

Villejuif, France

RECRUITING

Maastro

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Unilateral Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Marie Bergeaud, PhD

CONTACT

+33 (0) 6 28 68 47 15; m-bergeaud@unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: September 23, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: May 19, 2026

Record last verified: 2025-11

Locations

FR (26); NL (1)