Hematologic Disease
Conditions
Keywords
hematologic disease candidates for autologous or allogeneic bone marrow
Brief summary
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).
Interventions
DEVICECaphosol
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.
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 ®.
Sponsors
Jazz Pharmaceuticals
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assess the cost-effectiveness ratio is the number of days with severe mucositis won. | up to 28 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 number of days without medication morphine won | up to 28 days |
| 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 |
| - The incidence and duration of treatment of anti-infective and antifungal | 28 jours |
Countries
France
Outcome results
None listed