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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
92
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 ®.
Nantes Universty Hospital
Nantes, France
assess the cost-effectiveness ratio is the number of days with severe mucositis won.
Time frame: up to 28 days
The number of days without medication morphine won
Time frame: up to 28 days
Aggregate saving medicines prescribed Supportive
Time frame: up to 28 days
The incidence of mucositis
Time frame: up to 28 days
The intensity of pain assessed with a visual analogue scale
Time frame: up to 28 days
The cumulative dose of morphine administered and the number of days of treatment,
Time frame: 28 days
The duration of febrile neutropenia
Time frame: up to 28 days
- The incidence and duration of treatment of anti-infective and antifungal
Time frame: 28 jours
The incidence of total parenteral nutrition
Time frame: up to 28 days
- The duration of Release aplasia (ANC> 500/mm3),
Time frame: up to 28 days
The duration of the hospitalization
Time frame: participants will be followed for the duration of hospital stay, an expected average of 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The severity of mucositis
Time frame: up to 28 days
The duration of pain assessed with a visual analogue scale,
Time frame: up to 28 days