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| Name | Class |
|---|---|
| Jazz Pharmaceuticals | INDUSTRY |
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The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caphosol | Experimental |
| |
| Référence | Active Comparator | •Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® : |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caphosol | Device | The Caphosol ™ is a recently launched medical in France (2009). (source: laboratory EUSA Pharma ®) The product is an aqueous solution for mouthwash that comes in the form of a hyper-saturated mixture of calcium phosphate at neutral pH to reconstitute immediately before use. Each patient randomized to the treatment arms in the study will receive daily at least 4 (maximum 10) mouthwash Caphosol ™. The treatments are to begin preventive J1 to chemotherapy and continued until out of aplasia (ANC> 500/mm3), and / or mucositis grade 0. |
| Measure | Description | Time Frame |
|---|---|---|
| assess the cost-effectiveness ratio is the number of days with severe mucositis won. | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| The number of days without medication morphine won | up to 28 days | |
| Aggregate saving medicines prescribed Supportive | up to 28 days | |
| The incidence of mucositis |
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Inclusion Criteria:
Patient receiving:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Gastinne, M D | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes Universty Hospital | Nantes | 44200 | France |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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|
| Bicarbonate de sodium | Drug | Treatment of the early start on the day of conditioning and stop when the ANC> 500/mm3 and / or mucositis grade zero, provisional date of bone exceeded. Versylène: Method of administration: gargle made with a minute from 15 to 30 mL, 2-5 times a day, alternating with PAROEX ®. |
|
| up to 28 days |
| The intensity of pain assessed with a visual analogue scale | up to 28 days |
| The cumulative dose of morphine administered and the number of days of treatment, | 28 days |
| The duration of febrile neutropenia | up to 28 days |
| - The incidence and duration of treatment of anti-infective and antifungal | 28 jours |
| The incidence of total parenteral nutrition | up to 28 days |
| - The duration of Release aplasia (ANC> 500/mm3), | up to 28 days |
| The duration of the hospitalization | participants will be followed for the duration of hospital stay, an expected average of 28 days |
| The severity of mucositis | up to 28 days |
| The duration of pain assessed with a visual analogue scale, | up to 28 days |