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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

Study acronym: PRAVACUR-02
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 12, 2025 (before its estimated January 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Jun 30, 2024 to Jan 31, 2026
    • Study completion date: Jun 30, 2025 to Jan 31, 2031
    • Start date: Sep 28, 2020 to Jan 31, 2020
    v6
  2. Notable Primary completion date: Jun 30, 2022 to Jun 30, 2024v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2020 to Sep 28, 2020
    • Site details revised
    v3
  5. Notable Start date: Jun 30, 2020 to Sep 2020v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 them will develop severe and chronic radio-induced toxicities, such as breast radio-induced-fibrosis impairing their quality of life (QoL). Yet, paying attention to symptom improves the empowerment and psychological adjustment to the disease. Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been shown to prompt clinicians to intensify symptom management, to improve symptom control, and to enhance patient-clinician communication patient satisfaction, as well as well-being.Benefits of systems to elicit e-PRO improve reliable measure of health-related quality of life (QoL) remains discussed. To date, there are few specific treatments for these severe radio-induced fibrosis except the antifibrotic combinaison Pentoxifylline/Vitamin E with inconsistent result. Since 2000, we and others have developed a mechanistic approach modulating the severity of RIF by targeting the Rho/ROCK/CTGF pathway, especially by inhibiting Rho activation by pravastatin. Our preclinical data, then followed by the Phase II PRAVACUR-01 trial, concluded that the use of pravastatin has an anti-fibrotic action on different experimental models and reduces the severity of the grade of fibrosis in 50% of patients. Patients can now benefit from this new anti-fibrotic agent. Taken as a whole, these data encourage combining both drug (pravastatin) and non-pharmacological intervention , in particular e-PRO, in the RIF management.
Trial Details
NCT Number NCT04356209
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov