- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02271893
Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management (CHEMODEX)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63003
- Lise LACLAUTRE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 ...)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dextromethorphan
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.
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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.
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Placebo Comparator: placebo
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure of average pain intensity by a numerical rating scale
Time Frame: 7 days before the visit at 1 month
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7 days before the visit at 1 month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain assessment by DN4
Time Frame: at 1 month
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at 1 month
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total neuropathy score clinical version (TNSc)
Time Frame: at 1 month
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at 1 month
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St Antoine questionnaire (QDSA)
Time Frame: at 1 month
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at 1 month
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Evaluation of analgesic consumption
Time Frame: at 1 month
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at 1 month
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Cognitive assessment by Trail Making Test A and B
Time Frame: at 1 month
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at 1 month
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Cognitive assessment by Digit Symbol Substitution Test
Time Frame: at 1 month
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at 1 month
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Cognitive assessment by FACT-COG test
Time Frame: at 1 month
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at 1 month
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Cognitive assessment by Purdue Pegboard Test
Time Frame: at 1 month
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at 1 month
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Quality of life assessment by EORTC QLQ-C30
Time Frame: at 1 month
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at 1 month
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Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
Time Frame: at 1 month
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at 1 month
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Quality of life assessment by Patient Global Impression of Change (PGIC)
Time Frame: at 1 month
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at 1 month
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Anxiety and Depression assessment by HAD scale
Time Frame: at 1 month
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at 1 month
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Respiratory System Agents
- Antitussive Agents
- Dextromethorphan
Other Study ID Numbers
- CHU-0214
- 2014-000971-19 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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