This clinical trial focuses on patients who have developed severe breast fibrosis as a result of radiation therapy following breast cancer treatment. The study is investigating the effects of a medication called Pravastatin on improving the quality of life related to breast health. Breast fibrosis is a condition where the breast tissue becomes thickened and scarred, often leading to discomfort and changes in appearance. The trial aims to see if using Pravastatin can help alleviate these symptoms and improve the overall well-being of patients.
The purpose of the study is to evaluate how the use of electronic patient-reported outcomes, or e-PROs, can benefit patients’ quality of life when they are treated with Pravastatin for one year. e-PROs are digital tools that allow patients to report their symptoms and experiences directly to their healthcare providers, which can help in managing their condition more effectively. The study will compare two groups: one group will use e-PROs alongside their treatment, while the other group will receive standard care without e-PROs. This comparison will help determine if e-PROs provide additional benefits in managing breast fibrosis symptoms.
Participants in the study will take Pravastatin orally for a period of 12 months. Throughout the study, their breast-related quality of life will be monitored and assessed at various intervals, including at the start, after 12 months, and during follow-up visits up to 60 months. The study will also track the use of other medications like antidepressants and pain relievers, as well as any changes in psychological well-being. By the end of the study, researchers hope to understand better how Pravastatin and e-PROs can improve the lives of patients dealing with severe breast fibrosis after breast cancer treatment.



France