Actively Recruiting
Improving Empowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin and the Benefit of Electronic Patient Reported Outcomes on Breast-related Quality of Life
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-02-12
105
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of pravastatin combined with electronic patient-reported outcomes (e-PRO) to improve quality of life for patients with severe breast fibrosis caused by radiation therapy after breast-conserving surgery for breast cancer. This phase 2 trial aims to assess how monitoring symptoms through a web-based system and treating with pravastatin might reduce fibrosis severity and enhance patients' psychological adjustment and empowerment during recovery. Participants are randomly assigned to one of two groups: one receives pravastatin 40 mg daily along with the e-PRO system to report symptoms like pain, anxiety, sadness, and breast texture changes; the other group receives pravastatin alone without e-PRO monitoring. The e-PRO intervention uses a web platform where patients rate their symptoms weekly on severity and impact, helping clinicians manage symptoms more effectively. Treatment continues for 12 months. During the study, patients complete symptom questionnaires and quality of life assessments at baseline and multiple times up to 60 months. Researchers monitor use of medications like antidepressants and analgesics, psychological distress, pravastatin safety, and anti-fibrotic effects. The primary measure is breast-related quality of life over the first 12 months. Relapse-free survival is tracked for up to 5 years. Patients are carefully followed for side effects and changes in care prompted by e-PRO alerts, supporting comprehensive evaluation of this combined approach.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breast cancer patients treated by conserving surgery followed by adjuvant radiotherapy
- Age 18 years or older
- At least grade 2 breast radio-induced fibrosis
- Available treatment planning data of breast cancer radiotherapy
- Specific laboratory values within 15 days prior to randomization: serum creatinine ≤ 130 µmol/l; ASAT and ALAT ≤ 2N; total bilirubin ≤ 1.5N; CK levels < 3 x ULN for women aged 70 or older
- Negative pregnancy test for women of childbearing potential
- No contraindication to pravastatin treatment
- Signed and dated written consent
- Affiliation to a French Social Security System
You will not qualify if you...
- Any breast cancer recurrences
- Current treatment with statins, fibrates, ciclosporin, systemic fusidic acid, or long-term corticosteroids
- History of muscular dystrophy or chronic/hereditary muscular diseases
- Untreated hypothyroidism
- Laboratory values exceeding thresholds: serum creatinine > 130 µmol/l; ASAT and ALAT > 2N; total bilirubin > 1.5N
- CK levels > 3 x ULN in women over 70
- Known positive test for HIV, hepatitis B surface antigen, or hepatitis C antibody
- Pregnant or breastfeeding women
- Women of childbearing potential unwilling to use adequate contraception from study start to 4 weeks after last dose
- Known hypersensitivity to pravastatin or any product component
- Alcohol misuse
- Treatment with systemic investigational drugs within past 30 days
- Legal incapacity or physical, psychological, or mental status interfering with informed consent or study completion
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Day 0 to Month 12
Participants take Pravastatin 40 mg daily and may use the e-PRO platform to report symptoms related to breast fibrosis.
Regular use of the e-PRO web interface during treatment; visit schedule not specified
Duration - Up to 5 years
Participants are monitored for relapse-free survival and quality of life assessments continue up to 5 years after treatment starts.
Assessments at baseline, 12, 24, 36, 48, and 60 months
Trial Site Locations
Total: 1 location
1
ICM Val d'Aurelle
Montpellier, France, 34298
Actively Recruiting
Research Team
B
BOURGIER MD CELINE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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