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Study on Pravastatin for Patients with Severe Radio-Induced Breast Fibrosis After Breast Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous breast cancer treatment, and current health status.

    A signed and dated written consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health-related quality of life using specific questionnaires.

    Laboratory tests are performed to ensure safe participation, including checks on kidney and liver function.

  3. Step 3

    Pravastatin treatment

    The treatment involves taking pravastatin orally. The dosage and frequency are determined by the study protocol.

    The treatment duration is one year, during which the medication is taken regularly as prescribed.

  4. Step 4

    E-PROs monitoring

    Electronic Patient Reported Outcomes (e-PROs) are used to monitor symptoms and quality of life.

    Alerts are generated if severe or worsening symptoms are reported, prompting clinical review.

  5. Step 5

    Regular follow-up visits

    Regular follow-up visits are scheduled to assess health-related quality of life and psychological well-being.

    These visits occur at baseline, 12 months, and during follow-up at 24, 36, 48, and 60 months.

  6. Step 6

    End of treatment assessment

    At the end of the 12-month treatment period, a comprehensive assessment is conducted.

    This includes evaluating any changes in breast-related quality of life and other health parameters.

  7. Step 7

    Long-term follow-up

    Long-term follow-up continues beyond the treatment period to monitor ongoing health and any recurrence of symptoms.

    This includes periodic assessments and potential additional consultations if needed.

Who can join the trial?

12 criteria

  • Must have had breast cancer and been treated with surgery that conserves the breast, followed by radiation therapy.
  • Must be over 18 years old.
  • Must have at least grade 2 breast RIF, which means a certain level of breast tissue hardening due to radiation.
  • Must have available treatment planning data from the breast cancer radiation therapy.
  • Must have specific laboratory test results within 15 days before joining the study:
    • Serum creatinine (a kidney function test) must be 130 micromoles per liter or less.
    • ASAT and ALAT (liver function tests) must be 2 times the normal level or less.
    • Total bilirubin (a liver function test) must be 1.5 times the normal level or less.
    • CPK-MM levels (a muscle enzyme test) must be less than 3 times the upper normal limit, only for women aged 70 years or older.
    • Women who can have children must have a negative pregnancy test within 15 days before joining the study. Women who cannot have children include those who are postmenopausal or have had permanent sterilization procedures like tubal occlusion, hysterectomy, or bilateral salpingectomy.
    • Must not have any medical reasons that prevent treatment with **Pravastatin**.
    • Must provide signed and dated written consent to participate in the study.
    • Must be affiliated with the French Social Security System.

Who cannot join the trial?

5 criteria

  • Patients who do not have severe breast fibrosis caused by radiation after breast cancer treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not female or male, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Pravastatin is a medication used in this clinical trial to treat patients with severe breast fibrosis caused by radiation. The study aims to see if using this medication for one year can improve the quality of life related to breast health. The trial also involves monitoring patients' symptoms electronically to alert clinicians if there are severe or worsening symptoms.

What is already known about the treatment

Pravastatin – Pravastatin is administered orally in tablet form. It is currently being studied for its potential benefits in improving the quality of life for patients with severe breast fibrosis caused by radiation after breast cancer treatment. The main therapeutic indication in this context is to alleviate symptoms associated with this condition. At the molecular level, Pravastatin works by inhibiting an enzyme involved in cholesterol synthesis, which may also have anti-inflammatory effects that could benefit fibrosis. It is classified pharmacologically as a statin, primarily used to lower cholesterol levels.

Investigated diseases

Breast Fibrosis – Breast fibrosis is a condition characterized by the development of fibrous tissue in the breast, often as a result of radiation therapy for breast cancer. This fibrous tissue can cause the breast to feel firm or hard and may lead to discomfort or pain. Over time, the fibrosis can become more pronounced, potentially affecting the shape and texture of the breast. The condition may also lead to changes in skin appearance and can impact the overall quality of life for those affected. It is important to monitor the progression of fibrosis, as it can vary in severity among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515342-16-00Protocol codePROICM 2019-02 PRAEstimated enrolment102 patientsSponsorInstitut Regional Du Cancer De Montpellier

sourced from the EU Clinical Trials Register and site verification

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