Improving quality of life for breast cancer patients with severe fibrosis using pravastatin and electronic reporting

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to enhance the quality of life for breast cancer patients suffering from severe radio-induced fibrosis by utilizing pravastatin and electronic patient-reported outcomes (e-PROs). The study will involve patients who have undergone conserving surgery followed by adjuvant radiotherapy and are experiencing significant symptoms. By implementing a web-based system for e-PROs, the trial seeks to improve symptom management and communication between patients and clinicians, ultimately aiming to empower patients in their treatment journey. The effectiveness of this approach will be evaluated through patient feedback and health-related quality of life measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Breast cancer patients treated by conserving surgery followed by adjuvant RT
2. Over 18 years old
3. At least, grade 2 breast RIF
4. Treatment planning data of breast cancer radiotherapy must be available
5. The following laboratory values obtained ≤ 15 days prior to randomization:

   Serum creatinine ≤ 130 µmol/l; ASAT and ALAT≤ 2N; total bilirubin ≤ 1.5N; CK levels \< 3 x ULN, only for the women ≥ 70 years
6. Negative pregnancy test (β-HCG dosage) in women of childbearing potential (women not of reproductive potential are female patients who are postmenopausal or permanently sterilized: e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
7. Patient without contraindication to treatment with pravastatin
8. Signed and dated written consent
9. Patient must be affiliated to a French Social Security System

Exclusion Criteria:

1. Any breast cancer recurrences
2. Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids
3. History of muscular dystrophy diseases or chronic and/or hereditary muscular diseases
4. Untreated hypothyroidism
5. Serum creatinine \> 130 µmol/l; ASAT and ALAT \> 2N; total bilirubin \> 1.5N
6. CK levels \> 3 x ULN in women over 70 years
7. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody
8. Pregnant or breastfeeding women
9. Women of childbearing potential who are unwilling to employ adequate contraception, from the beginning of the study to 4 weeks after last treatment dose
10. Known hypersensitivity to pravastatin, or any constituent of the product.
11. Patient with alcohol misuse.
12. Patients treated with systemic investigational drugs within the past 30 days
13. Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Where it's running

• ICM Val d'Aurelle
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Bourgier Md Celine
• Email: celine.bourgier@ivm.unicancer.fr
• Phone: 0467612354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.