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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Gustave Roussy, Cancer Campus, Grand Paris
Ministry of Health, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: December 28, 2010
Last updated: June 9, 2016
Last verified: June 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 Intervention Phase
Drug: Pravastatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Fibrosis grade according to NCI-CTCAE v4 toxicities scale. [ Time Frame: 12 months ]
  • Quality of life [ Time Frame: 12 months ]
    VQ-Dermato scale

Estimated Enrollment: 55
Study Start Date: December 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pravastatin
Pravastatin : 40mg/day during 12 months
Drug: Pravastatin
Pravastatin 40mg/day during 12 months


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. any chronic treatment by corticoids
  2. severe cardiac pathology
  3. patients already treated by statins or treated by fibrates, cyclosporine
  4. history of muscular toxicities when treated by fibrates or by statins
  5. Personal or familial history of hereditary muscular pathology
  6. Plasmatic CPK >3 UNL
  7. patient already included in another therapeutic trial with an experimental drug,
  8. pregnant patient or susceptible to pregnancy or breast feeding (patients in age to give birth must be placed under efficient contraception),
  9. 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,
  10. the patient is under legal restrained or tutelage.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01268202

Contact: Sofia Rivera, MD
Contact: Aurélie Abou Lovergne

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   
Contact: Anne AUPERIN, MD, PhD    33 1 42 11 54 99   
Principal Investigator: Céline BOURGIER, MD, PhD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Ministry of Health, France
Study Chair: Sofia Rivera, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Additional Information:
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT01268202     History of Changes
Other Study ID Numbers: CSET 1383 - PRAVACUR
Study First Received: December 28, 2010
Last Updated: June 9, 2016

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
cutaneous radioinduced fibrosis

Additional relevant MeSH terms:
Pathologic Processes
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on May 24, 2017