Official Title
Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Phase
Phase 2Lead Sponsor
University Clermont AuvergneStudy Type
InterventionalStatus
TerminatedIndication/Condition
Chemotherapy-induced Peripheral NeuropathyIntervention/Treatment
dextromethorphan ...Study Participants
19The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing dextromethorphan and placebo for the treatment of chemotherapy-induced peripheral neuropathy, assessed with a (0-10) numerical scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.
The influence of CYP2D6, CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
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 ...)
