Status:
TERMINATED
Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Dr Gisèle PICKERING
Dr Dominique JOLY / Dr Christine VILLATTE
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 neuropa...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- \- 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
- \- 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 ...)
Key Trial Info
Start Date :
November 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02271893
Start Date
November 25 2014
End Date
April 21 2022
Last Update
October 10 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lise LACLAUTRE
Clermont-Ferrand, France, 63003