Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis
Status:
Completed
Trial end date:
2019-04-18
Target enrollment:
Participant gender:
Summary
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.