Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic " Patient Reported Outcome ") on Breast-related Quality of Life
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
You may not be if
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.
Clareo Health | Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic " Patient Reported Outcome ") on Breast-related Quality of Life
