Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital

Study Overview
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Brief Summary
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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).

Official Title
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Pharmaco-economic Cost-effective Prospective Randomized Trial Evaluating the Open Interest Caphosol ® Mouthwashes in the Prevention and Treatment of Severe Oral Mucositis in Patients Receiving High-dose Chemotherapy in Hematology

Conditions
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Hematologic Disease

Intervention / Treatment
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* Device: Caphosol
* Drug: Bicarbonate de sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years Patient receiving: Conditioning of autologous bone marrow transplantation by high dose melphalan (HD) as part of the management of myeloma or BEAM in lymphoma. A conditioning allogeneic bone marrow transplantation with reduced or intermediate busulfan IV Patients belong to a schema of social security, having signed the written informed consent. Exclusion Criteria: patients: To receive or have received KGF With previous history of RT with the exception of patients who received spinal analgesic therapy in the treatment of myeloma Unable or unwilling to complete the self assessment questionnaire With previous history of allergy to any component of the products under consideration Minor Adults under guardianship Pregnant women Patients who have not signed the consent form Creation of mouthwash out of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caphosol<br> | Device: Caphosol<br>* 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.<br>|
| Active Comparator: Référence<br>•Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® : | Drug: Bicarbonate de sodium<br>* 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 ®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the cost-effectiveness ratio is the number of days with severe mucositis won. |  | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematologic disease candidates for autologous or allogeneic bone marrow