PENTOCLORandomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial

Fecha de inicio: 1 de marzo de 2011

Inclusion Criteria: * Past-history of post-operative or exclusive irradiation (RT) for currently in remission cancer, in particular * breast cancer with breast or thoracic anterior wall RT; axilla-subclavicular lymph nodes RT; sometimes lung or head/neck cancer * Lymphoma (Hodgkin or non Hodgkin) with axilla-subclavicular RT (upper limb) or lumbar-aortic (lower limbs) or testis tumor * Delay RT-RIP more than 6 months, but partial RIP * Neurological injury in irradiated volume confirmed by EMG * Patient living within distance compatible with day-hospitalization * Use of effective contraception for fertile women * Signed written informed consent (in case of motor paralysis informed consent is signed by a witness) Exclusion Criteria: * Localized or metastatic cancer recurrence (axillar MRI or PET scan) * Complete plexus injury with total motor paralysis of upper/ lower limb for more than 2 years * Associated neurological disease that may interferer with the assessment of endpoints * Hemorrhage, disease with hemorrhagic risk, unbalanced diabetes * Known hypersensitivity to Pentoxifylline, one of the excipients or biphosphonates * Renal failure, liver failure or decompensated heart failure * Taking another biphosphonate * Evolving virosis (hepatitis, herpes, zona) or live vaccine (influenza) * Uncontrolled psychotic condition * Informed consent not obtained * Fertile women who do not want or cannot use effective contraception during the administration of study drugs * Women pregnant or nursing