Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

• Status: Unknown status
• Trial end date: 2019-10-25
• Target enrollment: 0
• Participant gender: Female

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 neuropathy compared to placebo group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Dr Dominique JOLY / Dr Christine VILLATTE; Dr Gisèle PICKERING; Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD; Pr Claude DUBRAY
• Treatments: Dextromethorphan

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 ...)