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| Name | Class |
|---|---|
| Clinact | OTHER |
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Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.
Use of the product EvonailĀ® was demonstrated in a patient treated by doxetaxel and having nail damage.
The purpose of this study is to confirm the effectiveness of the film-forming solution EvonailĀ® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental |
|
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| ARM B | Active Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evonail | Device | film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the film-forming solution EvonailĀ® versus placebo on nail damage | Efficacy will be evaluated by the oncologist according to NCI-CTC | up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Different types of nail damage observed in each group after chemotherapy docetaxel | Nail damage will be evaluated by the dermatologist based on photography according to NCI-CTC | up to 9 weeks |
| Patient compliance for the film-forming solution EvonailĀ® |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UWER Lionel, MD | Institut de CancƩrologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de Lorraine | VandÅuvre-lĆØs-Nancy | 54519 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Placebo excipient | Device | film forming excipient solution |
|
Patient compliance will be evaluated using a questionnaire
| up to 9 weeks |
| Patient satisfaction regarding the use of the film-forming solution EvonailĀ® | Patient satisfaction will be evaluated using a questionnaire | up to 9 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |