"Pharmaco-economic Cost-effective Single-center 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 '
Recruitment status was Recruiting
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).
Drug: Bicarbonate de sodium
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
- assess the cost-effectiveness ratio is the number of days with severe mucositis won. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- The number of days without medication morphine won [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Aggregate saving medicines prescribed Supportive [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- - The incidence and severity of mucositis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- The intensity and duration of pain assessed with a visual analogue scale, [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- The cumulative dose of morphine administered and the number of days of treatment, [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- the incidence and duration of febrile neutropenia [ Time Frame: 28 jours ] [ Designated as safety issue: No ]
- - The incidence and duration of treatment of anti-infective and antifungal [ Time Frame: 28 jours ] [ Designated as safety issue: No ]
- The incidence and duration of total parenteral nutrition, [ Time Frame: 28 jours ] [ Designated as safety issue: No ]
- - The duration of Release aplasia (ANC> 500/mm3), [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- The duration of the hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
Active Comparator: Référence
•Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® :
Drug: Bicarbonate de sodium
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 ®.
|Contact: Thomas Gastinne, MDfirstname.lastname@example.org|
|Nantes Universty Hospital||Recruiting|
|Nantes, France, 44200|
|Contact: Thomas Gastinne, M D|
|Contact: Mohammad Mohty|
|Principal Investigator:||Thomas Gastinne, M D||Nantes University Hospital|