Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis (PRAVACUR)
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|ClinicalTrials.gov Identifier: NCT01268202|
Recruitment Status : Unknown
Verified June 2016 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Recruiting
First Posted : December 29, 2010
Last Update Posted : June 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibrosis||Drug: Pravastatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
Pravastatin : 40mg/day during 12 months
Pravastatin 40mg/day during 12 months
- 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.
- Fibrosis grade according to NCI-CTCAE v4 toxicities scale. [ Time Frame: 12 months ]
- Quality of life [ Time Frame: 12 months ]VQ-Dermato scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268202
|Contact: Sofia Rivera, MDemail@example.com|
|Contact: Aurélie Abou Lovergnefirstname.lastname@example.org|
|Centre Val d'Aurelle||Not yet recruiting|
|Montpellier, France, 34298|
|Contact: David AZRIA, MD|
|Principal Investigator: David AZRIA, MD|
|Hôpital Européen Georges Pompidou||Not yet recruiting|
|Paris, France, 75015|
|Contact: Philippe GIRAUD, MD|
|Principal Investigator: Philippe GIRAUD, MD|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, 94805|
|Contact: Céline BOURGIER, MD, PhD 33 1 42 11 49 31 email@example.com|
|Contact: Anne AUPERIN, MD, PhD 33 1 42 11 54 99 firstname.lastname@example.org|
|Principal Investigator: Céline BOURGIER, MD, PhD|
|Study Chair:||Sofia Rivera, MD||Gustave Roussy, Cancer Campus, Grand Paris|