Clinical trial NCT02271893: Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Official title: Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Chemotherapy-induced peripheral neuropathy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Dr Gisèle PICKERING
name: Dr Dominique JOLY / Dr Christine VILLATTE
name: Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD
name: Pr Claude DUBRAY
First posted: 2014-10-22
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 neuropathy compared to placebo group.

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 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.

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 ...)

Primary outcomes:
measure: Measure of average pain intensity by a numerical rating scale
timeFrame: 7 days before the visit at 1 month
Secondary outcomes:
measure: Pain assessment by DN4
timeFrame: at 1 month
measure: total neuropathy score clinical version (TNSc)
timeFrame: at 1 month
measure: St Antoine questionnaire (QDSA)
timeFrame: at 1 month
measure: Evaluation of analgesic consumption
timeFrame: at 1 month
measure: Cognitive assessment by Trail Making Test A and B
timeFrame: at 1 month
measure: Cognitive assessment by Digit Symbol Substitution Test
timeFrame: at 1 month
measure: Cognitive assessment by FACT-COG test
timeFrame: at 1 month
measure: Cognitive assessment by Purdue Pegboard Test
timeFrame: at 1 month
measure: Quality of life assessment by EORTC QLQ-C30
timeFrame: at 1 month
measure: Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
timeFrame: at 1 month
measure: Quality of life assessment by Patient Global Impression of Change (PGIC)
timeFrame: at 1 month
measure: Anxiety and Depression assessment by HAD scale
timeFrame: at 1 month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Lise LACLAUTRE
Study officials:
References:
citation: Martin E, Morel V, Joly D, Villatte C, Delage N, Dubray C, Pereira B, Pickering G. Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy. Contemp Clin Trials. 2015 Mar;41:146-51. doi: 10.1016/j.cct.2015.01.012. Epub 2015 Jan 28.