Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management (CHEMODEX)

University Hospital, Clermont-Ferrand

Status and phase

Terminated

Phase 2

Conditions

Chemotherapy-induced Peripheral Neuropathy

Treatments

Drug: Dextromethorphan

Study type

Interventional

Funder types

Other

Identifiers

NCT02271893

CHU-0214

2014-000971-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

19 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 ...)