CHEMODEX: Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| 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. |
Drug: 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.
|
| 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. |
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Measure of average pain intensity by a numerical rating scale [7 days before the visit at 1 month]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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- 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
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Numerical rating scale ≥ 4
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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)
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Patients affiliated to the French Social Security
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Patients with free and informed consent has been obtained
Exclusion Criteria:
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- Hypersensitivity to the active substance or to any of the excipients
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Hypertension
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History of stroke
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Severe heart failure
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Severe hepatic impairment
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Shortness of breath
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Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency
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Association with linezolid
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Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy
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Diabetes (type I and II)
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Medical and surgical history incompatible with the study
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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
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Present or past psychotropic substances and alcohol dependence
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Childbearing age, no use of effective contraceptive method, pregnancy or lactation
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Patient exclusion period, or the total allowable compensation exceeded
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Patients undergoing a measure of legal protection (guardianship, supervision ...)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Clermont-Ferrand | Clermont-Ferrand | France | 63003 |
Sponsors and Collaborators
- University Hospital, Clermont-Ferrand
- Dr Gisèle PICKERING
- Dr Dominique JOLY / Dr Christine VILLATTE
- Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD
- Pr Claude DUBRAY
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHU-0214
- 2014-000971-19