An interventional study of XAINET AI tool in Unilateral Breast Neoplasms, sponsored by UNICANCER. Recruiting at 27 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by UNICANCER · Not applicable, Interventional, and Prevention
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:
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:
Exclusion Criteria:
Device: XAINET AI tool
The AI-based prediction of arm lymphedema risk is communicated to the patient and treating physician.
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
Time frame: At 2 years
Impact of communicating the risk prediction for arm lymphedema on the choice of radiotherapy modality, fractionation, technique and nodal levels irradiated
Radiotherapy modalities: technique used, fractionation (use of moderately and ultra-hypofractionated), and lymph node levels treated will be compared in both arms
Time frame: Up to 3 months from randomization.
Acute and late toxicity during the study
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders
Time frame: Throughout study completion, up to 2 years.
Range of shoulder motion (ROM) of the arms
The range of shoulder motion (ROM) of the arms (flexion/abduction) will be reported by the radiation oncologist according to a circular scale
Time frame: Throughout study completion, up to 2 years.
Breast cosmetic result
The global cosmetic result after breast conservation surgery will be based on Harris 4-point scale (4-point Likert scale: Excellent, Good, Fair, Poor)
Time frame: Throughout study completion, up to 2 years.
Performance of the arm lymphedema risk prediction model
The performance will be assessed by the discrimination and the calibration of the model in the control arm. The discrimination refers to how well the model differentiates patients at higher risk of having an event from those at lower risk. For assessing discrimination at fixed time point of occurrence of event of interest, the area under the receiver operating characteristic curve (AUC) will be calculated. The calibration expresses the agreement between the observed and predicted outcome values. To assess whether the observed event rate equals the predicted risk in different groups of predicted risks, calibration curve will be created.
Time frame: At 2 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level
Time frame: At baseline, end of treatment visit, 1 year and 2 years
Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)
This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms
Time frame: At baseline, end of treatment visit, 1 year and 2 years
The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire
Developed by the EuroQol group, the self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS) The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 5 levels (1 = "no problems", 2 = "slight problems", 3 = "moderate problems", 4 = "severe problems", and 5 = "extreme problems"). This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 0 (The best health you can image) to 100 (The worst health you can image). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement
Time frame: At baseline, end of treatment visit, 1 year and 2 years
Compliance with compression arm sleeve use
Compliance with the use of the compression arm sleeve will be measured by the frequency with which the patient wears it according to the patient
Time frame: At end of treatment visit, 3-month after starting radiotherapy, at 1 year and 2 years
Loco-regional relapse-free survival (RFS)
Locoregional recurrence-free survival is the time from randomisation until locoregional recurrence (as the first recurrence event) or death
Time frame: From randomization until the first invasive ipsilateral breast tumor recurrence, loco regional invasive recurrence, ipsilateral DCIS or death from any cause up to 2 years
Distant disease-free survival (DDFS)
Distant disease-free survival is defined as the time from randomization until the recurrence of disease (first, occurrence of metastasis or distant relapse) or death from any cause using DATECAN definitions of breast-cancer related endpoints
Time frame: From randomization until the recurrence of disease or death from any cause up to 2 years
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive
Time frame: From randomization to death from any cause, up to 2 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UNICANCER