PRE-ACT-01_v 2.0 28Nov2025
Research type
Research Study
Full title
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: PRE-ACT-01 clinical investigation
IRAS ID
363228
Contact name
Tim Rattay
Contact email
Sponsor organisation
Unicancer
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 15 days
Research summary
As part of the European PRE-ACT project, an artificial intelligence (AI) tool has been developed to estimate an individual patient’s risk of developing arm lymphedema after breast cancer treatment. This condition can cause swelling of the arm following radiotherapy to the breast and lymph nodes. The risk is communicated to patients and clinicians through a web-based application. This application explains the factors that contribute to each person’s risk and provides information on possible preventive or supportive measures, such as wearing a compression sleeve, which may help reduce the risk.
The main aim of the PRE-ACT-01 international study is to assess the effect of providing personalised risk predictions for arm lymphedema using an AI tool. Up to 724 patients will take part in the study. Half of the participants will be informed of their individual risk of developing arm lymphedema, while the other half will not receive the personalised risk.
By comparing these two groups, the study will examine whether the use of the AI tool influences the number of patients who develop arm lymphedema after treatment.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
26/YH/0124
Date of REC Opinion
18 Jun 2026
REC opinion
Favourable Opinion