Status:
RECRUITING
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
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Conserving surgery followed by adjuvant radiotherapy is currently the therapeutic standard for patient with Breast Cancer. Symptoms are common among patients receiving this treatment. Ten percent of t...
Eligibility Criteria
Inclusion
- Breast cancer patients treated by conserving surgery followed by adjuvant RT
- Over 18 years old
- At least, grade 2 breast RIF
- Treatment planning data of breast cancer radiotherapy must be available
- 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
- 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).
- Patient without contraindication to treatment with pravastatin
- Signed and dated written consent
- Patient must be affiliated to a French Social Security System
Exclusion
- Any breast cancer recurrences
- Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids
- History of muscular dystrophy diseases or chronic and/or hereditary muscular diseases
- Untreated hypothyroidism
- Serum creatinine \> 130 µmol/l; ASAT and ALAT \> 2N; total bilirubin \> 1.5N
- CK levels \> 3 x ULN in women over 70 years
- Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody
- Pregnant or breastfeeding women
- Women of childbearing potential who are unwilling to employ adequate contraception, from the beginning of the study to 4 weeks after last treatment dose
- Known hypersensitivity to pravastatin, or any constituent of the product.
- Patient with alcohol misuse.
- Patients treated with systemic investigational drugs within the past 30 days
- Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
Key Trial Info
Start Date :
January 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2031
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04356209
Start Date
January 31 2020
End Date
January 31 2031
Last Update
February 12 2025
Active Locations (1)
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1
ICM Val d'Aurelle
Montpellier, France, 34298