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NCT Number: NCT01268202

Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis

Molecular mechanisms involved in radio-induced fibrosis are assessed in UPRES EA 27-10 since 10 years. Besides the canonical TGFbeta/ Smad pathway involved in radio-induced fibrosis (RIF), the Rho/ROCK/CTGF cascade has been shown to be also implicated in molecular mechanisms of RIF. Curative administration of Pravastatin or ROCK specific inhibitors inhibits the chronically activated Rho/ROCK/CTGF pathway in vitro in human cells lines and ex vivo in human samples. In addition, the curative administration of Pravastatin improves established RIF in vivo. The investigators data suggest that the pravastatin-based strategy is an efficient and safe antifibrotic therapy, easily transferable into the clinic to improve the quality of life of long-term cancer survivors without interfering with prior anticancer treatment.

This clinical trial evaluates the curative efficacy of Pravastatine in patients who presented a cutaneous and/ or subcutaneous fibrosis (grade >= 2 according to NCI-CTCAE v4 toxicities scale) and who were treated by radiotherapy for a head and neck cancer. Patients will be treated by Pravastatin during 12 months. An intermediate evaluation of efficacy by ultrasound will be assessed at 6 months and at last, at the end of the treatment. Patients assessment will be performed at 6 and 12 months after the end of the treatment to look at a potential rebound effect.

Objective(s) of the clinical study

Main objective: To assess Pravastatin efficacy in established cutaneous and subcutaneous radio-induced fibrosis revealed from 6 to 24 months after head and neck radiotherapy.

Second objective: To evaluate radio-induced fibrosis regression during the year following treatment stop.

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Key information

Conditions

Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Val d'Aurelle, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Grade >= 2 cutaneous and/or subcutaneous fibrosis (NCI-CTCAE v4 toxicities scale) revealed from 6 to 24 months after head and neck radiotherapy.
  • Head and neck cancers treated by radiation therapy +/- chemotherapy, +/- surgery, with no evidence of progressive disease.
  • Age >= 18
  • Karnofsky PS ≥ 70
  • normal renal function (plasmatic creatinine <= 130 micromol/l), normal cholesterol, normal hepatic function (total bilirubin <= 1.5 UNL, SGOT and SGPT <= 2 UNL)
  • Written informed consent of the patient.

Exclusion criteria

  • any chronic treatment by corticoids
  • severe cardiac pathology
  • patients already treated by statins or treated by fibrates, cyclosporine
  • history of muscular toxicities when treated by fibrates or by statins
  • Personal or familial history of hereditary muscular pathology
  • Plasmatic CPK >3 UNL
  • patient already included in another therapeutic trial with an experimental drug,
  • pregnant patient or susceptible to pregnancy or breast feeding (patients in age to give birth must be placed under efficient contraception),
  • a social or psychological condition that does not allow a positive patient's participation in the treatment and necessary medical follow-up to be envisaged,
  • the patient is under legal restrained or tutelage.

Treatment and study plan

Pravastatin

Drug

Pravastatin 40mg/day during 12 months

Primary outcomes

  1. regression of radio-induced fibrosis (RIF) evaluated by high frequency ultrasound

    Time frame: 12 months

    a decrease of the maximal thickness more than 30% compared to RIF before treatment.

Secondary outcomes

  1. Fibrosis grade according to NCI-CTCAE v4 toxicities scale.

    Time frame: 12 months

  2. Quality of life

    Time frame: 12 months

    VQ-Dermato scale

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: PRAVACUR

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2010
Registry last updated
Jun 13, 2019

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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