Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT01268202
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01268202
Study Brief:
Protocol Section:
NCT01268202