A Phase 2 interventional study of e-PRO Intervention and Pravastatin in Breast Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Phase 2, Interventional, and Treatment
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 105 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 142 studies on the registry; 50 are open to participants now.
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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
Exclusion Criteria:
ePRO intervention + PRAVASTATINE treatment
Other: e-PRO Intervention · Drug: Pravastatin
PRAVASTATINE treatment ( without ePRO)
Drug: Pravastatin
Statements of symptoms and patients' health status (PROs) will be collected via a web interface, including access and use in patients with burden symptoms. The platform will include four items concerning 7 side effects of fibrosis of grade \> 2 in breast cancer. Patients will be encouraged to evaluate on a 5-point Likert scale the frequency, the intensity and the repercussions on the daily life of some symptoms during the last 7 days, in particular on: * general pain * anxiety * sadness * texture of the treated breast * Patients will also be invited to express themselves on the severity of two other symptoms of their choice, to their worst degree, by listing and rating them on a 5-point scale ranging from "None" to "Very severe" Finally, the aesthetic impact will be evaluated by patients on a visual analogue scale (VAS) of 0 to 100mm
Also known as: Electronic-Patient Reported Outcomes
All patients will take Pravastatin 40 mg per day (From Day 0 to Month 12).
evaluate the benefit on breast-related quality of life of systematic e-PROs
The BRQoL improvement rate at 12 months, compared with baseline, defined as: * an improvement of 5 points (or more) of the score assessed by the functional scale "body image" of the QLQ-BR23 (summary score including the items # 39-42), or * a reduction of 5 points (or more) of the score on the symptom scale "breast symptoms" assessed by the QLQ-BR23 (summary score including the items # 51- 53).
Time frame: From randomization to 12 months
evaluate the patients'HRQoL
defined by the Health-related quality of life assessed by the EORTC QLQ-C30 and its module BR23
Time frame: at baseline;12,24, 36, 48 and 60 months
estimate the use of antidepressants
defined by the rate and dose of used antidepressants
Time frame: From randomization to 12 months
estimate the use of analgesics
defined by the rate and dose of used analgesics
Time frame: From randomization to 12 months
estimate the use of anxiolytics
defined by the rate and dose of used anxiolytics
Time frame: From randomization to 12 months
Assess the levels of psychological distress
assessed by (HADS) Scale : score {min :0 (no Distress) --- max :21 ( Hight Distress) }
Time frame: at baseline; at 12, 24, 36, 48 and 60 months
monitor the e-PROs alerts in the experimental group
Timing of the e-PROs alerts and the care management (phone call or planning of a consultation, treatment initiation)
Time frame: From randomization to 12 months
characterise the evaluation of the side effects linked to RIF in the experimental group
Evolution of the 7 different e-PROs scores across time (general pain { 0 (no pain)- 4 (high pain)}, anxiety{ 0 (no anxiety)- 4 (high anxiety)}, sadness { 0 (no sad)- 4 (high sad)}, texture of the treated breast{ 0 (no sweeling)- 4 (high sweeling)}, two other symptoms assessed by the PRO-CTCAE scales { 0 (none)- 4 (severe)}, and scores of aesthetic impact assesses by a Visual Analog Scale{ 0 (no impact)- 100 (max impact)}
Time frame: From randomization to 12 months
characterise the modifications of the patients' management in the experimental group
Number of hospital emergency visits or hospitalizations
Time frame: From randomization to 12 months
evaluate the anti-fibrotic efficacy of pravastatin
Number of supplementary consultations
Time frame: From randomization to 12 months
evaluate the pravastatin safety
Regression rate of at least 1 grade of fibrosis (follow-up of fibrosis grade evolution since inclusion)
Time frame: From randomization to 12 months
estimate the relapse-free survival
Relapse-free survival defined as the time from the date of randomization to the date of the first observed oncological event such as local, ipsilateral, regional or metastatic recurrence or death for any cause
Time frame: Until study completion: 5 years
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