Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Drug: Dextromethorphan


Participation Criteria
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Eligibility Criteria
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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 ...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextromethorphan<br>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. | Drug: Dextromethorphan<br>* 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.<br>|
| Placebo Comparator: placebo<br>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. | Drug: Dextromethorphan<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of average pain intensity by a numerical rating scale |  | 7 days before the visit at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment by DN4 |  | at 1 month | 
| total neuropathy score clinical version (TNSc) |  | at 1 month | 
| St Antoine questionnaire (QDSA) |  | at 1 month | 
| Evaluation of analgesic consumption |  | at 1 month | 
| Cognitive assessment by Trail Making Test A and B |  | at 1 month | 
| Cognitive assessment by Digit Symbol Substitution Test |  | at 1 month | 
| Cognitive assessment by FACT-COG test |  | at 1 month | 
| Cognitive assessment by Purdue Pegboard Test |  | at 1 month | 
| Quality of life assessment by EORTC QLQ-C30 |  | at 1 month | 
| Quality of life assessment by Pittsburg Sleep Quality Index (PSQI) |  | at 1 month | 
| Quality of life assessment by Patient Global Impression of Change (PGIC) |  | at 1 month | 
| Anxiety and Depression assessment by HAD scale |  | at 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy-induced peripheral neuropathy