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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000971-19 | EudraCT Number |
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Recruitment difficulties
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| Name | Class |
|---|---|
| Dr Gisèle PICKERING | UNKNOWN |
| Dr Dominique JOLY / Dr Christine VILLATTE | UNKNOWN |
| Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD | UNKNOWN |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextromethorphan | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of average pain intensity by a numerical rating scale | 7 days before the visit at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment by DN4 | at 1 month | |
| total neuropathy score clinical version (TNSc) | at 1 month | |
| St Antoine questionnaire (QDSA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lise LACLAUTRE | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25636304 | Derived | 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. |
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| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Pr Claude DUBRAY |
| UNKNOWN |
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| 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 |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |