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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01291433
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT01291433
Study Brief:
Protocol Section:
NCT01291433