NCT01426295已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- assess the cost-effectiveness ratio is the number of days with severe mucositis won.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Adults under guardianship
- •Pregnant women
- •Patients who have not signed the consent form
- •Creation of mouthwash out of the study
研究组 & 干预措施
Caphosol
Experimental
干预措施: Caphosol (Device)
Référence
Active Comparator
•Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® :
干预措施: Bicarbonate de sodium (Drug)
结局指标
主要结局
assess the cost-effectiveness ratio is the number of days with severe mucositis won.
时间窗: up to 28 days
次要结局
- Aggregate saving medicines prescribed Supportive(up to 28 days)
- The intensity of pain assessed with a visual analogue scale(up to 28 days)
- - The duration of Release aplasia (ANC> 500/mm3),(up to 28 days)
- The severity of mucositis(up to 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 number of days without medication morphine won(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 incidence of mucositis(up to 28 days)
- The cumulative dose of morphine administered and the number of days of treatment,(28 days)
- The incidence of total parenteral nutrition(up to 28 days)
- The duration of pain assessed with a visual analogue scale,(up to 28 days)
研究者
研究点 (1)
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