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

NCT04356209 | Recruiting Phase 2 DMC

• 1 other identifier: PROICM 2019-02 PRA
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  From randomization to 12 months

Secondary Outcomes (11)

• evaluate the patients'HRQoL

  at baseline;12,24, 36, 48 and 60 months

• estimate the use of antidepressants

  From randomization to 12 months

• estimate the use of analgesics

  From randomization to 12 months

• estimate the use of anxiolytics

  From randomization to 12 months

• Assess the levels of psychological distress

  at baseline; at 12, 24, 36, 48 and 60 months

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

ePRO intervention + PRAVASTATINE treatment

Other: e-PRO Intervention; Drug: Pravastatin

CONTROL GROUP

OTHER

PRAVASTATINE treatment ( without ePRO)

Drug: Pravastatin

Interventions

e-PRO Intervention OTHER

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

EXPERIMENTAL GROUP

Pravastatin DRUG

All patients will take Pravastatin 40 mg per day (From Day 0 to Month 12).

CONTROL GROUP; EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any breast cancer recurrences
• Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids
• History of muscular dystrophy diseases or chronic and/or hereditary muscular diseases
• Untreated hypothyroidism
• Serum creatinine \> 130 µmol/l; ASAT and ALAT \> 2N; total bilirubin \> 1.5N
• CK levels \> 3 x ULN in women over 70 years
• Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody
• Pregnant or breastfeeding women
• Women of childbearing potential who are unwilling to employ adequate contraception, from the beginning of the study to 4 weeks after last treatment dose
• Known hypersensitivity to pravastatin, or any constituent of the product.
• Patient with alcohol misuse.
• Patients treated with systemic investigational drugs within the past 30 days
• Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

ICM Val d'Aurelle

Montpellier, 34298, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

BOURGIER MD CELINE

CONTACT

0467612354; celine.bourgier@ivm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 22, 2020
• Study Start: January 31, 2020
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2031
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

FR (1)