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NCT Number: NCT04356209

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ICM Val d'Aurelle

Montpellier, 34298, France

Location status: Recruiting

Location contact

BLEUSE Jean-pierre

CONTACT

[email protected]

00467613102

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Electronic-Patient Reported Outcomes

Pravastatin

Drug

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

Primary outcomes

  1. evaluate the benefit on breast-related quality of life of systematic e-PROs

    Time frame: From randomization to 12 months

    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).

Secondary outcomes

  1. evaluate the patients'HRQoL

    Time frame: at baseline;12,24, 36, 48 and 60 months

    defined by the Health-related quality of life assessed by the EORTC QLQ-C30 and its module BR23

  2. estimate the use of antidepressants

    Time frame: From randomization to 12 months

    defined by the rate and dose of used antidepressants

  3. estimate the use of analgesics

    Time frame: From randomization to 12 months

    defined by the rate and dose of used analgesics

  4. estimate the use of anxiolytics

    Time frame: From randomization to 12 months

    defined by the rate and dose of used anxiolytics

  5. Assess the levels of psychological distress

    Time frame: at baseline; at 12, 24, 36, 48 and 60 months

    assessed by (HADS) Scale : score {min :0 (no Distress) --- max :21 ( Hight Distress) }

  6. monitor the e-PROs alerts in the experimental group

    Time frame: From randomization to 12 months

    Timing of the e-PROs alerts and the care management (phone call or planning of a consultation, treatment initiation)

  7. characterise the evaluation of the side effects linked to RIF in the experimental group

    Time frame: From randomization to 12 months

    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)}

  8. characterise the modifications of the patients' management in the experimental group

    Time frame: From randomization to 12 months

    Number of hospital emergency visits or hospitalizations

  9. evaluate the anti-fibrotic efficacy of pravastatin

    Time frame: From randomization to 12 months

    Number of supplementary consultations

  10. evaluate the pravastatin safety

    Time frame: From randomization to 12 months

    Regression rate of at least 1 grade of fibrosis (follow-up of fibrosis grade evolution since inclusion)

  11. estimate the relapse-free survival

    Time frame: Until study completion: 5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

BOURGIER MD CELINE

CONTACT

[email protected]

0467612354

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Acronym: PRAVACUR-02

Important dates

Study start
2020
Primary completion
2026
Study completion
2031
First posted
Apr 22, 2020
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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