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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT02271893
Eligibility Criteria:
Inclusion Criteria:
* \- Age ≥ 18 years
* Breast cancer patients suffering from chemotherapy-induced peripheral neuropathy for at least 3 months after the end of their last cancer chemotherapy
* Numerical rating scale ≥ 4
* Patient in stable clinical situation on the next month (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled in the month following the enrollment)
* Patients affiliated to the French Social Security
* Patients with free and informed consent has been obtained
Exclusion Criteria:
* \- Hypersensitivity to the active substance or to any of the excipients
* Hypertension
* History of stroke
* Severe heart failure
* Severe hepatic impairment
* Shortness of breath
* Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency
* Association with linezolid
* Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy
* Diabetes (type I and II)
* Medical and surgical history incompatible with the study
* Patient receiving treatment with amantadine, ketamine, memantine, L-Dopa, dopaminergic agonists, anticholinergics, barbiturates, neuroleptics, Monoamine oxidase inhibitor, dantrolene or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, amiodarone, fluoxetine, paroxetine, propafenone, thioridazine, ritonavir, nicotine, hydrochlorothiazide, warfarin
* Present or past psychotropic substances and alcohol dependence
* Childbearing age, no use of effective contraceptive method, pregnancy or lactation
* Patient exclusion period, or the total allowable compensation exceeded
* Patients undergoing a measure of legal protection (guardianship, supervision ...)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02271893
Study Brief:
Protocol Section:
NCT02271893