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 is this study for? Patients with Breast Cancer
What treatments are being studied? Pravastatin
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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; CK levels \< 3 x ULN, only for the women ≥ 70 years

• 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).

• Patient without contraindication to treatment with pravastatin

• Signed and dated written consent

• Patient must be affiliated to a French Social Security System

Locations
Other Locations
France
ICM Val d'Aurelle
RECRUITING
Montpellier
Contact Information
Primary
BOURGIER MD CELINE
celine.bourgier@ivm.unicancer.fr
0467612354
Time Frame
Start Date: 2020-01-31
Estimated Completion Date: 2031-01-31
Participants
Target number of participants: 105
Treatments
Experimental: EXPERIMENTAL GROUP
ePRO intervention + PRAVASTATINE treatment
Other: CONTROL GROUP
PRAVASTATINE treatment ( without ePRO)
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov