Improving quality of life for breast cancer patients with severe fibrosis using pravastatin and electronic reporting
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
This study is testing if using pravastatin and a web-based reporting system can help breast cancer patients with severe fibrosis feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT04356209 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adult breast cancer patients who have undergone conserving surgery and adjuvant radiotherapy, and are experiencing grade 2 or higher breast radio-induced fibrosis.
Not a fit: Patients with recurrent breast cancer or those currently on specific contraindicated treatments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for breast cancer patients suffering from severe fibrosis.
How similar studies have performed: While there are few specific treatments for severe radio-induced fibrosis, the use of e-PROs has shown promise in improving patient outcomes in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montpellier
- ICM Val d'Aurelle — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Bourgier Md Celine
- Email: celine.bourgier@ivm.unicancer.fr
- Phone: 0467612354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.