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Improving the empowerment 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
EU CTIS ID: 2024-515342-16-00
What this study is testing
The main objective of this study is to evaluate at 12 months the benefit on breast-related quality of life (BRQoL) of systematic e-PROs (alerting the clinicians in case of severe or worsening symptoms) in BC patients treated by Pravastatin during 1 year for severe breast RIF. A standard surveillance group receiving conventional care (without e-PROs) will constitute an internal control group (control group).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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; CPK-MM levels < 3 x ULN, only for the women ≥ 70 years.
- Negative pregnancy test (β-HCG dosage ≤ 15 days prior to randomization) 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).
You likely can't join if
- 1. Any breast cancer recurrences.
- 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.
- Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids.
See the full eligibility criteria
- 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; CPK-MM levels < 3 x ULN, only for the women ≥ 70 years.
- Negative pregnancy test (β-HCG dosage ≤ 15 days prior to randomization) 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
- 1. Any breast cancer recurrences.
- 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.
- 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.
- CPK-MM 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.